{"id":28609,"date":"2024-07-08T15:49:32","date_gmt":"2024-07-08T10:19:32","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=28609"},"modified":"2025-03-10T14:56:22","modified_gmt":"2025-03-10T09:26:22","slug":"donanemab-for-alzheimers-disease-treatment","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/donanemab-for-alzheimers-disease-treatment","title":{"rendered":"A New Dawn in Alzheimer\u2019s Disease Treatment: Eli Lilly\u2019s Donanemab Wins FDA Approval"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a020138e9db9\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a020138e9db9\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/donanemab-for-alzheimers-disease-treatment\/#The_Birth_of_a_Breakthrough\" >The Birth of a Breakthrough<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/donanemab-for-alzheimers-disease-treatment\/#Donanemab_Clinical_Triumphs\" >Donanemab: Clinical Triumphs<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/donanemab-for-alzheimers-disease-treatment\/#Navigating_Regulatory_Waters\" >Navigating Regulatory Waters<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/donanemab-for-alzheimers-disease-treatment\/#Donanemab_Cost_and_Coverage\" >Donanemab: Cost and Coverage<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/donanemab-for-alzheimers-disease-treatment\/#A_New_Challenger_Implications_for_Biogen\" >A New Challenger: Implications for Biogen<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.delveinsight.com\/blog\/donanemab-for-alzheimers-disease-treatment\/#Donanemab_Comparative_Performance\" >Donanemab: Comparative Performance<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.delveinsight.com\/blog\/donanemab-for-alzheimers-disease-treatment\/#Strengthening_Lillys_Position_in_Alzheimers_Disease_Treatment\" >Strengthening Lilly\u2019s Position in Alzheimer\u2019s Disease Treatment<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.delveinsight.com\/blog\/donanemab-for-alzheimers-disease-treatment\/#Alzheimers_Disease_Market_Reaction_and_Future_Prospects\" >Alzheimer\u2019s Disease Market Reaction and Future Prospects<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.delveinsight.com\/blog\/donanemab-for-alzheimers-disease-treatment\/#Alzheimers_Disease_Treatment_Inspiring_Future_R_D\" >Alzheimer\u2019s Disease Treatment: Inspiring Future R&amp;D<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.delveinsight.com\/blog\/donanemab-for-alzheimers-disease-treatment\/#Alzheimers_Disease_Competitive_Landscape\" >Alzheimer\u2019s Disease Competitive Landscape<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.delveinsight.com\/blog\/donanemab-for-alzheimers-disease-treatment\/#Voices_from_the_Field\" >Voices from the Field<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.delveinsight.com\/blog\/donanemab-for-alzheimers-disease-treatment\/#A_New_Chapter_in_Alzheimers_Disease_Treatment\" >A New Chapter in Alzheimer\u2019s Disease Treatment<\/a><\/li><\/ul><\/nav><\/div>\n\n<p>The world of Alzheimer\u2019s disease treatment witnessed a groundbreaking moment recently as the FDA approved <strong>Eli Lilly\u2019s donanemab<\/strong>, marketed as <strong>KISUNLA<\/strong>. This new drug brings hope to millions of patients and their families struggling with this debilitating disease. Let us delve into the fascinating journey of donanemab, from its inception to its game-changing approval.\u00a0<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-the-birth-of-a-breakthrough\"><span class=\"ez-toc-section\" id=\"The_Birth_of_a_Breakthrough\"><\/span><strong>The Birth of a Breakthrough<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Eli Lilly\u2019s donanemab is a monoclonal antibody specifically designed to target amyloid-beta plaques in the brain, which are strongly associated with Alzheimer\u2019s disease. This innovative approach aims to slow the progression of cognitive decline in patients with early symptomatic Alzheimer\u2019s disease, offering a glimmer of hope where options have been limited.<\/p>\n\n\n\n<p>The story of donanemab began in the early 2010s, when Lilly\u2019s scientists, building on decades of research, zeroed in on the potential of targeting amyloid plaques. Early studies showed promise, sparking a series of clinical trials that tested the drug\u2019s efficacy and safety. Despite numerous challenges, the persistence and dedication of Lilly\u2019s team paved the way for this revolutionary treatment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-donanemab-clinical-triumphs\"><span class=\"ez-toc-section\" id=\"Donanemab_Clinical_Triumphs\"><\/span><strong>Donanemab: Clinical Triumphs<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In the <a href=\"https:\/\/www.delveinsight.com\/blog\/donanemab-phase-iii-trailblazer-alz-2-trial\">TRAILBLAZER-ALZ 2 Phase III study<\/a>, patients who were less advanced in their disease showed the strongest results with KINSUNLA. Participants were divided into two groups: those with low to medium levels of tau protein (less advanced) and the overall population, which included those with high tau levels. Treatment with KINSUNLA significantly slowed clinical decline in both groups. Those in the less advanced group experienced a <strong>35%<\/strong> slowing of decline compared to the placebo on the integrated Alzheimer\u2019s Disease Rating Scale (iADRS), which measures memory, thinking, and daily functioning. In the overall population, the slowing of decline was <strong>22%<\/strong>, also statistically significant. Moreover, KINSUNLA reduced the risk of progressing to the next clinical stage by up to <strong>39%<\/strong> compared to placebo.<\/p>\n\n\n\n<p>Among the overall population, KINSUNLA reduced amyloid plaques by an average of <strong>61%<\/strong> at 6 months, <strong>80%<\/strong> at 12 months, and <strong>84%<\/strong> at 18 months compared to baseline. One of the study\u2019s treatment goals was to reduce amyloid plaques to minimal levels, consistent with a visually negative scan using amyloid positron emission tomography (PET). Participants who achieved these levels could switch to a placebo for the remainder of the study.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-navigating-regulatory-waters\"><span class=\"ez-toc-section\" id=\"Navigating_Regulatory_Waters\"><\/span><strong>Navigating Regulatory Waters<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>KINSUNLA, like other approved <a href=\"https:\/\/www.delveinsight.com\/report-store\/alzheimers-disease-ad-market\">Alzheimer\u2019s disease drugs<\/a>, presents notable safety concerns, including brain swelling and hemorrhaging, known as amyloid-related imaging abnormalities (ARIA). Its label mandates more frequent brain MRI scans compared to its competitor, LEQEMBI, which is perceived to have a more favorable safety profile. KINSUNLA\u2019s regulatory journey was challenging yet compelling; the FDA initially rejected its accelerated approval request due to concerns about limited long-term data. However, the agency later granted full approval after an advisory committee unanimously endorsed the drug\u2019s efficacy and safety.<\/p>\n\n\n\n<p>Designated as a breakthrough therapy for Alzheimer\u2019s disease, KISUNLA\u2019s journey was bolstered by the promising results from the Phase II TRAILBLAZER-ALZ study, which demonstrated a slowed progression of the disease. Following these findings, Eli Lilly initiated a rolling submission of a Biologics License Application (BLA) for donanemab. Additionally, donanemab has received several expedited regulatory designations from the FDA, including Fast Track, Priority Review, and Breakthrough Therapy status, which facilitated its approval process within the Alzheimer\u2019s disease treatment market.<\/p>\n\n\n\n<p>Thus, the approval of KINSUNLA marks a significant milestone in Alzheimer\u2019s disease treatment, providing a new option for patients with early symptomatic disease. A unique aspect of KINSUNLA is that patients can discontinue treatment once amyloid plaques are sufficiently reduced, a milestone achieved by nearly half of the study participants within 12 months. This feature has the potential to lower treatment costs and reduce the burden of infusions. However, it also raises questions about the long-term durability of KINSUNLA effects.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-donanemab-cost-and-coverage\"><span class=\"ez-toc-section\" id=\"Donanemab_Cost_and_Coverage\"><\/span><strong>Donanemab: Cost and Coverage<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>KISUNLA\u2019s potential to lower treatment burden and costs, combined with its capability to slow the progression of AD, positions it as a valuable addition to the limited treatment options for this debilitating condition. Its approval comes at a timely juncture, particularly as Biogen and Eisai\u2019s earlier drugs, <a href=\"https:\/\/www.delveinsight.com\/blog\/leqembi-for-alzheimers-disease-treatment\">LEQEMBI<\/a> and ADUHELM, have helped delineate Alzheimer\u2019s treatment coverage pathways within the Centers for Medicare &amp; Medicaid Services. Medicare is expected to cover KISUNLA\u2019s cost in the US, following the Centers for Medicare and Medicaid Services\u2019 earlier commitment to funding new Alzheimer\u2019s medications with full FDA approval. However, as part of this framework, the company is expected to enroll patients in real-world data collection registries to validate the ongoing efficacy of their products. Physicians will also be required to gather data on how effectively the drugs perform in real-world settings.&nbsp;<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"575\" src=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/07\/08154809\/Development-Timeline-for-KISUNLA-1024x575.png\" alt=\"Development Timeline for KISUNLA\" class=\"wp-image-28628\" srcset=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/07\/08154809\/Development-Timeline-for-KISUNLA-1024x575.png 1024w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/07\/08154809\/Development-Timeline-for-KISUNLA-300x168.png 300w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/07\/08154809\/Development-Timeline-for-KISUNLA-150x84.png 150w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/07\/08154809\/Development-Timeline-for-KISUNLA-768x431.png 768w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/07\/08154809\/Development-Timeline-for-KISUNLA-1536x862.png 1536w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/07\/08154809\/Development-Timeline-for-KISUNLA-2048x1150.png 2048w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/07\/08154809\/Development-Timeline-for-KISUNLA-1568x880.png 1568w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p>As of now, the list price for KISUNLA will be approximately <strong>USD 32,000<\/strong> for a course of therapy lasting a year. It is administered as a monthly 30-minute infusion, which is less frequent than the every two-week infusion schedule for competitor drugs. Additionally, Eli Lilly offers a free support program called Lilly Support Services for KISUNLA to help patients navigate treatment, including coverage determination assistance and other resources. The company also intends to donate KISUNLA to the Lilly Cares Foundation, a nonprofit organization that provides medications at no cost to qualified Americans who meet financial eligibility.<\/p>\n\n\n\n<p>Though the price of KISUNLA is not necessarily lower than other Alzheimer\u2019s drugs; however, its potential for treatment discontinuation, reduced infusion burden, and available support services could lead to lower overall treatment costs and out-of-pocket expenses for eligible patients, making it a more cost-effective option in the long run.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-a-new-challenger-implications-for-biogen\"><span class=\"ez-toc-section\" id=\"A_New_Challenger_Implications_for_Biogen\"><\/span><strong>A New Challenger: Implications for Biogen<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>KISUNLA enters a treatment arena already occupied by LEQEMBI, a similar drug approved. Both medications target the same pathology, but KISUNLA offers a potential advantage \u2013 it requires <strong>monthly infusions<\/strong> compared to LEQEMBI\u2019s bi-weekly schedule. This could make KISUNLA a more convenient option for patients struggling with the demands of treatment.<\/p>\n\n\n\n<p>Donanemab\u2019s approval may prompt a reevaluation of LEQEMBI\u2019s market position and could influence ongoing research and development strategies within the industry.<\/p>\n\n\n\n<p>Unlike LEQEMBI, which requires ongoing treatment, KINSUNLA allows patients to discontinue therapy once their amyloid levels, a key marker of Alzheimer\u2019s disease, fall below a certain threshold. This unique feature of KINSUNLA could potentially reduce overall treatment costs in the long run despite its higher initial price. While the upfront cost of KINSUNLA is higher, its ability to halt treatment upon reaching therapeutic milestones could make it a more cost-effective option over time.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-donanemab-comparative-performance\"><span class=\"ez-toc-section\" id=\"Donanemab_Comparative_Performance\"><\/span><strong>Donanemab: Comparative Performance<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>When compared to other amyloid-targeting therapies, donanemab has shown similar or superior efficacy, with a more favorable safety profile in certain aspects. For instance, donanemab demonstrated a significant reduction in amyloid plaques over 18 months, with up to 84% reduction from baseline. This compares favorably with Biogen and Eisai\u2019s LEQEMBI, which also targets amyloid plaques but has different safety and efficacy profiles.<\/p>\n\n\n\n<p>LEQEMBI has shown promise in reducing cognitive decline, but donanemab\u2019s unique trial design, which includes a limited-duration dosing regimen, offers a distinct advantage. Patients on donanemab can complete treatment once amyloid plaques are reduced to minimal levels, potentially reducing long-term treatment costs and improving patient compliance compared to the continuous dosing required by LEQEMBI.<\/p>\n\n\n\n<p>ADUHELM, another drug in this category, was approved in 2021 but was discontinued by its manufacturer, Biogen, the following year due to insufficient evidence of patient benefit. Biogen has since shifted focus to developing a leading portfolio to address various aspects of the disease and better patient needs.<\/p>\n\n\n\n<p>Furthermore, donanemab targeting patients based on tau levels\u2014particularly those with low to medium tau\u2014could lead to more personalized and effective treatment strategies. This nuanced approach may enhance the overall efficacy and safety profile, providing a competitive edge over LEQEMBI.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strengthening-lilly-s-position-in-alzheimer-s-disease-treatment\"><span class=\"ez-toc-section\" id=\"Strengthening_Lillys_Position_in_Alzheimers_Disease_Treatment\"><\/span><strong>Strengthening Lilly\u2019s Position in Alzheimer\u2019s Disease Treatment<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The approval of donanemab solidifies Lilly\u2019s leadership in the <a href=\"https:\/\/www.delveinsight.com\/blog\/alzheimers-disease-treatment-and-clinical-trials\">Alzheimer\u2019s research and treatment arena<\/a>. It enhances the company\u2019s reputation and paves the way for further innovations in neurodegenerative diseases, reinforcing Lilly\u2019s commitment to improving patient outcomes.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-alzheimer-s-disease-market-reaction-and-future-prospects\"><span class=\"ez-toc-section\" id=\"Alzheimers_Disease_Market_Reaction_and_Future_Prospects\"><\/span><strong>Alzheimer\u2019s Disease Market Reaction and Future Prospects<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Investors\u2019 initial reaction to KISUNLA\u2019s FDA approval was a bit of a head-scratcher. Eli Lilly\u2019s stock price dipped slightly despite the momentous news. This hesitation stems from a wait-and-see approach. Key questions linger, like how negotiations with insurers will play out and how many patients will qualify for KISUNLA treatment. Competition from LEQEMBI also adds to the uncertainty. The high cost of the drug could limit patient access, and <a href=\"https:\/\/www.delveinsight.com\/report-store\/alzheimers-disease-ad-pipeline-insight\">future Alzheimer\u2019s disease treatment therapies<\/a> could erode KISUNLA\u2019s market share. Only time will tell if KISUNLA becomes a commercial success, but its approval undeniably bolsters Eli Lilly\u2019s position in the burgeoning Alzheimer\u2019s treatment market.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-alzheimer-s-disease-treatment-inspiring-future-r-amp-d\"><span class=\"ez-toc-section\" id=\"Alzheimers_Disease_Treatment_Inspiring_Future_R_D\"><\/span><strong>Alzheimer\u2019s Disease Treatment: Inspiring Future R&amp;D<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Donanemab\u2019s success is likely to inspire increased investment in Alzheimer\u2019s research and development. With a major treatment gap and historically low clinical trial success rates, this breakthrough serves as a beacon of hope, encouraging continued innovation and collaboration in the quest to conquer Alzheimer\u2019s. The promising results from donanemab will likely galvanize researchers and pharmaceutical companies to explore new avenues and mechanisms of action in the fight against Alzheimer\u2019s.<\/p>\n\n\n\n<p>Furthermore, donanemab ability to significantly slow cognitive decline in a targeted patient population based on tau levels sets a new benchmark for personalized medicine in neurodegenerative diseases. This approach could lead to more tailored and effective treatment regimens, spurring further research into biomarkers and individualized therapies.<\/p>\n\n\n\n<p>The approval of donanemab may also accelerate the development of combination therapies, where multiple drugs targeting different aspects of Alzheimer\u2019s pathology are used together. This could potentially address the complex nature of the disease more comprehensively than single-agent treatments. Overall, donanemab approval marks not just a victory for patients but also a significant leap forward in Alzheimer\u2019s research, promising a new era of innovation and hope in the battle against this devastating disease.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-alzheimer-s-disease-competitive-landscape\"><span class=\"ez-toc-section\" id=\"Alzheimers_Disease_Competitive_Landscape\"><\/span><strong>Alzheimer\u2019s Disease Competitive Landscape<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Alzheimer\u2019s disease market in the US is projected to grow significantly in the coming years, driven by the increasing prevalence among the aging population. Symptomatic treatments currently dominate the market, with limited availability of disease-modifying therapies. Key drug categories include amyloid \u03b2 protein inhibitors, nuclear factor kappa B (NF-\u03baB) inhibitors, tau aggregation inhibitors, acetylcholinesterase (AChE) inhibitors, N-methyl-D-aspartate receptor (NMDA-R) antagonists, tyrosine kinase inhibitors, and other neurotransmitter modulators. Numerous partnerships have been established among industry players to expand research efforts and product offerings. Major Key players in the <a href=\"https:\/\/www.delveinsight.com\/report-store\/alzheimers-disease-ad-market\">Alzheimer\u2019s disease market<\/a> include <strong>AB Science, AC Immune, Novo Nordisk, Novo Nordisk, Biogen, Eisai, Eli Lilly, and AriBio<\/strong>, among others, contributing to evolving market dynamics.<\/p>\n\n\n\n<p><span id=\"docs-internal-guid-f333fdc5-7fff-63c2-468a-6ff8427cff1f\"><\/span><\/p>\n<div dir=\"ltr\" style=\"margin-left: 0pt;\" align=\"left\">\n<table style=\"border: none; border-collapse: collapse;\"><colgroup><col width=\"156\" \/><col width=\"156\" \/><col width=\"156\" \/><col width=\"156\" \/><\/colgroup>\n<tbody>\n<tr style=\"height: 0pt;\">\n<td style=\"vertical-align: middle; background-color: #bfe6ff; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\" colspan=\"4\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: center; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Comparison of Emerging Drugs for Alzheimer&rsquo;s Treatment<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 0pt;\">\n<td style=\"vertical-align: middle; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Drug Name<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: middle; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Company<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: middle; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Mechanism of action<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: middle; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Phase<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 0pt;\">\n<td style=\"vertical-align: middle; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Bezisterim (NE3107)<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: middle; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">BioVie<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: middle; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">NF&kappa;B inhibitor, ERK inhibitor<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: middle; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">III<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 0pt;\">\n<td style=\"vertical-align: middle; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Valiltramiprosate (ALZ-801)<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: middle; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Alzheon<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: middle; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Amyloid beta-protein inhibitors\/Amyloid oligomer formation inhibitor<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: middle; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">III<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 0pt;\">\n<td style=\"vertical-align: middle; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Simufilam (PTI-125)<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: middle; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Cassava Sciences<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: middle; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Microfilament protein modulators<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: middle; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">III<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 18.85pt;\">\n<td style=\"vertical-align: middle; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Semaglutide (NN6535)<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: middle; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">Novo Nordisk<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: middle; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">GLP-1 receptor agonist<\/span><\/p>\n<\/td>\n<td style=\"vertical-align: middle; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: 400; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">III<\/span><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 0pt;\">\n<td style=\"vertical-align: top; background-color: #f5f5f5; padding: 0pt 5.4pt 0pt 5.4pt; overflow: hidden; overflow-wrap: break-word; border: solid #000000 1pt;\" colspan=\"4\">\n<p dir=\"ltr\" style=\"line-height: 1.2; text-align: justify; margin-top: 10pt; margin-bottom: 0pt;\"><span style=\"font-size: 11pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;\">The pipeline for Alzheimer&rsquo;s disease is robust, with assets in the early and late phases of development.<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Voices_from_the_Field\"><\/span><strong>Voices from the Field<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Key leaders have expressed a mix of enthusiasm and cautious optimism about donanemab.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>\u201c<em>These recent approvals generate hope for continued advances. For researchers, our next horizon is to develop new treatments that address different components of the disease and that work together to have an even bigger effect on slowing or stopping disease progression for all communities.\u201d<\/em><\/p>\n<cite><strong>Maria C. Carrillo, Ph.D., chief science officer and medical affairs lead, Alzheimer\u2019s Association.<\/strong><\/cite><\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><strong>\u201c<\/strong><em>This is real progress. Today\u2019s approval allows people more options and greater opportunity to have more time<\/em><strong>.\u201d<\/strong><\/p>\n<cite><strong>Joanne Pike, DrPH, Alzheimer\u2019s Association president and CEO<\/strong><\/cite><\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cIt is important to note that these drugs are not cures, and they can have serious side effects. Disease Modifying Therapies are only suitable for a small number of people who are in the early stages of Alzheimer\u2019s disease. There will be countless people for whom this drug will not be helpful. We must continue to advocate for and resource non-pharmacological interventions and supports for people with all types of dementia and their families.\u201d<\/em><\/p>\n<cite><strong>Dr Laura O\u2019Philbin, the ASI Research and Policy Manager<\/strong><\/cite><\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"A_New_Chapter_in_Alzheimers_Disease_Treatment\"><\/span><strong>A New Chapter in Alzheimer\u2019s Disease Treatment<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The approval of KISUNLA (donanemab) offers a new beacon of hope for millions of <a href=\"https:\/\/www.delveinsight.com\/report-store\/alzheimers-disease-ad-epidemiology-forecast\">Alzheimer\u2019s patients<\/a> and their families. The disease, which currently affects around <strong>6.3 million<\/strong> individuals in the US, is expected to become even more prevalent in the coming years due to an aging population, increased awareness, and advancements in diagnostic techniques. The burden of Alzheimer\u2019s on patients is immense, manifesting in memory loss, cognitive decline, and, ultimately, the loss of independence. For caregivers, the emotional, physical, and financial toll can be overwhelming.<\/p>\n\n\n\n<p>According to DelveInsight&#8217;s analysis, the US <a href=\"https:\/\/www.delveinsight.com\/report-store\/alzheimers-disease-ad-market\">market for Alzheimer&#8217;s disease<\/a> is expected to reach approximately <strong>USD 21 billion<\/strong> by 2032, with an anticipated compound annual growth rate (CAGR) of more than <strong>20% <\/strong>during the study period. This growth will be driven primarily by the expected approval of novel therapies, enhanced market access, and increasing prevalence of the disease. KINSUNLA is forecasted to lead with an estimated market value of around <strong>USD 8 billion<\/strong> by 2032. Following this, Hydromethylthionine mesylate (HMTM)\/TRx0237 and ANAVEX2-73\/blarcamesine, along with other treatments, is expected to contribute significantly to the market.<\/p>\n\n\n\n<p>With the potential to significantly impact patients, the market, and future research, donanemab stands as a testament to the power of innovation and perseverance in the face of one of medicine\u2019s greatest challenges.<\/p>\n\n\n\n<p>As we celebrate the advancement represented by KISUNLA, it is crucial to continue supporting the diverse needs of all Alzheimer\u2019s patients and their caregivers, ensuring comprehensive care and advancing research for more inclusive and effective treatments. The battle against Alzheimer\u2019s is far from over, but each new development brings us closer to a future where this devastating disease can be effectively managed, if not entirely eradicated.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><a href=\"https:\/\/www.delveinsight.com\/report-store\/alzheimers-disease-ad-market\"><img decoding=\"async\" width=\"1024\" height=\"194\" src=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/07\/08154718\/Alzheimers-Disease-Market-Outlook-and-Assessment-1024x194.png\" alt=\"Alzheimer\u2019s Disease Market Outlook and Assessment\" class=\"wp-image-28627\" srcset=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/07\/08154718\/Alzheimers-Disease-Market-Outlook-and-Assessment-1024x194.png 1024w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/07\/08154718\/Alzheimers-Disease-Market-Outlook-and-Assessment-300x57.png 300w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/07\/08154718\/Alzheimers-Disease-Market-Outlook-and-Assessment-150x28.png 150w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/07\/08154718\/Alzheimers-Disease-Market-Outlook-and-Assessment-768x145.png 768w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/07\/08154718\/Alzheimers-Disease-Market-Outlook-and-Assessment-1536x291.png 1536w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/07\/08154718\/Alzheimers-Disease-Market-Outlook-and-Assessment-1568x297.png 1568w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/07\/08154718\/Alzheimers-Disease-Market-Outlook-and-Assessment.png 1584w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>The world of Alzheimer\u2019s disease treatment witnessed a groundbreaking moment recently as the FDA approved Eli Lilly\u2019s donanemab, marketed as KISUNLA. This new drug brings hope to millions of patients and their families struggling with this debilitating disease. Let us delve into the fascinating journey of donanemab, from its inception to its game-changing approval.\u00a0 The [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":28625,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[17],"tags":[19079,7145,6642,6641,72,20371,21071],"industry":[17225],"therapeutic_areas":[17245],"class_list":["post-28609","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","tag-aduhelm","tag-alzheimers-disease-market","tag-alzheimers-disease-pipeline","tag-alzheimers-disease-therapies","tag-alzheimers-disease","tag-donanemab","tag-leqembi","industry-pharmaceutical","therapeutic_areas-neurology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA Approves Donanemab: Milestone in Alzheimer\u2019s Treatment<\/title>\n<meta name=\"description\" content=\"Alzheimer\u2019s disease treatment witnessed a groundbreaking moment recently as the FDA approved Eli Lilly\u2019s donanemab, marketed as KINSUNLA.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.delveinsight.com\/blog\/donanemab-for-alzheimers-disease-treatment\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Approves Donanemab: Milestone in Alzheimer\u2019s Treatment\" \/>\n<meta property=\"og:description\" content=\"Alzheimer\u2019s disease treatment witnessed a groundbreaking moment recently as the FDA approved Eli Lilly\u2019s donanemab, marketed as KINSUNLA.\" \/>\n<meta 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