{"id":26499,"date":"2024-01-02T18:12:30","date_gmt":"2024-01-02T12:42:30","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=26499"},"modified":"2024-05-14T14:16:41","modified_gmt":"2024-05-14T08:46:41","slug":"pharma-news-for-cytokinetics-chiesi-astrazeneca-zevra","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-cytokinetics-chiesi-astrazeneca-zevra","title":{"rendered":"Cytokinetics Announces Results From SEQUOIA-HCM Clinical Trial of Aficamten; FDA Approves Chiesi\u2019s FILSUVEZ Topical Gel; Bristol Myers Squibb Adds Premier Radiopharmaceutical Platform; AstraZeneca to Acquire Gracell; Zevra Therapeutics Announces Resubmission of Arimoclomol New Drug Application; Innovent Dosed First Participant in Phase 3 Clinical Study (GLORY-2) of Mazdutide (IBI362)"},"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-69d2a81fdc98e\" 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-69d2a81fdc98e\"  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\/pharma-news-for-cytokinetics-chiesi-astrazeneca-zevra\/#Cytokinetics_Announces_Positive_Results_From_SEQUOIA-HCM_the_Pivotal_Phase_III_Clinical_Trial_of_Aficamten_in_Patients_With_Obstructive_Hypertrophic_Cardiomyopathy\" >Cytokinetics Announces Positive Results From SEQUOIA-HCM, the Pivotal Phase III Clinical Trial of Aficamten in Patients With Obstructive Hypertrophic Cardiomyopathy<\/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\/pharma-news-for-cytokinetics-chiesi-astrazeneca-zevra\/#Chiesi_Global_Rare_Diseases_Receives_FDA_Approval_for_FILSUVEZ_Topical_Gel_for_the_Treatment_of_Epidermolysis_Bullosa\" >Chiesi Global Rare Diseases Receives FDA Approval for FILSUVEZ Topical Gel for the Treatment of Epidermolysis Bullosa<\/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\/pharma-news-for-cytokinetics-chiesi-astrazeneca-zevra\/#Bristol_Myers_Squibb_Adds_Premier_Radiopharmaceutical_Platform_with_Acquisition_of_RayzeBio\" >Bristol Myers Squibb Adds Premier Radiopharmaceutical Platform with Acquisition of RayzeBio<\/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\/pharma-news-for-cytokinetics-chiesi-astrazeneca-zevra\/#AstraZeneca_to_Acquire_Gracell_Furthering_Cell_Therapy_Ambition_Across_Oncology_and_Autoimmune_Diseases\" >AstraZeneca to Acquire Gracell, Furthering Cell Therapy Ambition Across Oncology and Autoimmune Diseases<\/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\/pharma-news-for-cytokinetics-chiesi-astrazeneca-zevra\/#Innovent_Dosed_First_Participant_in_Phase_3_Clinical_Study_GLORY-2_of_Mazdutide_IBI362_Higher_Dose_9_mg_in_Chinese_Adults_with_Obesity\" >Innovent Dosed First Participant in Phase 3 Clinical Study (GLORY-2) of Mazdutide (IBI362) Higher Dose 9 mg in Chinese Adults with Obesity&nbsp;<\/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\/pharma-news-for-cytokinetics-chiesi-astrazeneca-zevra\/#Zevra_Therapeutics_Announces_Resubmission_of_Arimoclomol_New_Drug_Application_to_the_US_Food_and_Drug_Administration\" >Zevra Therapeutics Announces Resubmission of Arimoclomol New Drug Application to the US Food and Drug Administration<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-cytokinetics-announces-positive-results-from-sequoia-hcm-the-pivotal-phase-iii-clinical-trial-of-aficamten-in-patients-with-obstructive-hypertrophic-cardiomyopathy\"><span class=\"ez-toc-section\" id=\"Cytokinetics_Announces_Positive_Results_From_SEQUOIA-HCM_the_Pivotal_Phase_III_Clinical_Trial_of_Aficamten_in_Patients_With_Obstructive_Hypertrophic_Cardiomyopathy\"><\/span><strong>Cytokinetics Announces Positive Results From SEQUOIA-HCM, the Pivotal Phase III Clinical Trial of Aficamten in Patients With Obstructive Hypertrophic Cardiomyopathy<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Cytokinetics, Incorporated <\/strong>released favorable top-line findings from the <strong>SEQUOIA-HCM trial<\/strong> (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the crucial Phase III clinical study evaluating aficamten in individuals experiencing symptomatic <a href=\"https:\/\/www.delveinsight.com\/report-store\/hypertrophic-cardiomyopathy-market\">obstructive hypertrophic cardiomyopathy (HCM)<\/a>.<\/p>\n\n\n\n<p>The findings from SEQUOIA-HCM indicate that the use of aficamten led to a notable enhancement in exercise capacity in comparison to a placebo. This improvement was evidenced by a statistically significant increase in peak oxygen uptake (pVO2) measured through cardiopulmonary exercise testing (CPET), with a least square mean difference (95% CI) of 1.74 (1.04 &#8211; 2.44) mL\/kg\/min (p=0.000002). Notably, the positive impact of aficamten on exercise capacity remained consistent across various patient subgroups, considering factors such as baseline characteristics and treatment strategies, including the use or non-use of background beta-blocker therapy.<\/p>\n\n\n\n<p>Significant improvements, both statistically (p&lt;0.0001) and clinically meaningful, were observed in all 10 predetermined secondary endpoints. These included enhancements in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) at weeks 12 and 24, an increase in the proportion of patients with a class improvement of \u22651 in New York Heart Association (NYHA) functional class at weeks 12 and 24, alterations in provoked left ventricular outflow tract gradient (LVOT-G) and the proportion below 30 mmHg at weeks 12 and 24, as well as improvements in exercise workload and eligibility for septal reduction therapy based on guidelines.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>&#8220;The outcomes of the SEQUOIA-HCM study have exceeded our expectations in terms of both effectiveness and safety. Aficamten, when added to standard care therapy, demonstrated a favorable impact on exercise capacity and exhibited prompt and sustained effects on symptoms and functional class in patients with obstructive HCM. These positive effects were achieved while maintaining the safety and tolerability observed in previous assessments. <\/em><strong><em>Dr. Fady I. Malik, Cytokinetics&#8217; Executive Vice President of Research &amp; Development<\/em><\/strong><em>, expressed confidence in the results, stating that they align with findings from the Phase 2 trial (REDWOOD-HCM) and the ongoing open-label extension trial (FOREST-HCM). He believes that these results may establish aficamten as the preferred cardiac myosin inhibitor among both physicians and patients. Dr. Malik expressed gratitude to the patients, investigators, and site personnel involved in SEQUOIA-HCM, emphasizing ongoing support for clinical research. The complete findings from this trial are anticipated to be shared at a medical meeting in 2024.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-chiesi-global-rare-diseases-receives-fda-approval-for-filsuvez-topical-gel-for-the-treatment-of-epidermolysis-bullosa\"><span class=\"ez-toc-section\" id=\"Chiesi_Global_Rare_Diseases_Receives_FDA_Approval_for_FILSUVEZ_Topical_Gel_for_the_Treatment_of_Epidermolysis_Bullosa\"><\/span><strong>Chiesi Global Rare Diseases Receives FDA Approval for FILSUVEZ Topical Gel for the Treatment of Epidermolysis Bullosa<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Chiesi Global Rare Diseases<\/strong>, a division within the Chiesi Group dedicated to providing innovative therapies and solutions for individuals grappling with rare diseases, has disclosed that the U.S. Food and Drug Administration (FDA) has granted approval for <strong>FILSUVEZ\u00ae (birch triterpenes) topical gel<\/strong>. This approval is specifically for the management of partial thickness wounds in individuals aged 6 months and older who are diagnosed with Junctional Epidermolysis Bullosa (JEB) and <a href=\"https:\/\/www.delveinsight.com\/report-store\/dystrophic-epidermolysis-bullosa-market\">Dystrophic Epidermolysis Bullosa (DEB)<\/a>. Notably, FILSUVEZ marks a groundbreaking advancement as the inaugural sanctioned treatment for wounds associated with JEB, an uncommon and severe form of Epidermolysis Bullosa characterized by blistering that initiates in infancy. It&#8217;s worth mentioning that FILSUVEZ became part of the Chiesi portfolio following the acquisition of Amryt Pharma in January of the previous year.<\/p>\n\n\n\n<p>Epidermolysis Bullosa is an incapacitating genetic skin condition that renders an individual&#8217;s skin extremely delicate, making it susceptible to damage even from gentle contact. This rare, persistent, and distressing ailment impacts individuals across all age groups, including infants, children, and adults, causing severe and recurring blistering along with persistent wounds that lead to unbearable pain and restricted mobility. Coping with epidermolysis bullosa involves facing daily hurdles, such as the slow healing of wounds that are prone to infection and undergoing painful dressing changes. FILSUVEZ offers a home-based treatment option, facilitating its incorporation into existing care routines. The application of FILSUVEZ directly onto the wound is part of the regular dressing change procedure.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>&#8220;At Chiesi Global Rare Diseases, our motivation stems from a commitment to easing the challenges encountered by the rare disease community. We strive to offer groundbreaking therapies and solutions that address significant unmet needs,&#8221; expressed <\/em><strong><em>Giacomo Chiesi, Head of Chiesi Global Rare Diseases.<\/em><\/strong><em> &#8220;We appreciate the backing of <\/em><a href=\"https:\/\/www.delveinsight.com\/report-store\/dystrophic-epidermolysis-bullosa-market\"><em>individuals living with Epidermolusis Bullosa<\/em><\/a><em> and their devoted caregivers, enabling us to achieve this noteworthy FDA approval and offer FILSUVEZ as an impactful solution for wound care management.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-bristol-myers-squibb-adds-premier-radiopharmaceutical-platform-with-acquisition-of-rayzebio\"><span class=\"ez-toc-section\" id=\"Bristol_Myers_Squibb_Adds_Premier_Radiopharmaceutical_Platform_with_Acquisition_of_RayzeBio\"><\/span><strong>Bristol Myers Squibb Adds Premier Radiopharmaceutical Platform with Acquisition of RayzeBio<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Bristol Myers Squibb<\/strong> and <strong>RayzeBio, Inc.<\/strong> have entered into a definitive merger agreement, where <strong>Bristol Myers Squibb will purchase RayzeBio at $62.50 per share in cash<\/strong>, totaling an equity value of roughly <strong>$4.1 billion<\/strong>, or <strong>$3.6 billion<\/strong> after considering estimated acquired cash. The boards of both companies unanimously approved this transaction.<\/p>\n\n\n\n<p>RayzeBio, a clinical-stage company specializing in radiopharmaceutical therapeutics, holds a leading position in actinium-based RPTs (Radiopharmaceutical Therapies) and maintains a pipeline comprising potentially pioneering drug development programs, aiming primarily at treating solid tumors such as <a href=\"https:\/\/www.delveinsight.com\/report-store\/gastroenteropancreatic-neuroendocrine-tumors-gep-nets-market\"><strong>GEP-NETs<\/strong><\/a>, <a href=\"https:\/\/www.delveinsight.com\/report-store\/non-small-cell-lung-cancer-nsclc-market\"><strong>small cell lung cancer<\/strong><\/a>, <a href=\"https:\/\/www.delveinsight.com\/report-store\/hepatocellular-carcinoma-market\"><strong>hepatocellular carcinoma<\/strong><\/a>, and others. There&#8217;s a notable demand for more effective treatments in solid tumors, and RPTs offer a precise approach to addressing this need by targeting tumor cells and delivering focused radiation to eliminate cancer cells. Actinium-based RPTs, particularly, exhibit potential advantages over existing therapies due to their high potency and limited radiation range, which could result in heightened efficacy and targeted delivery.<\/p>\n\n\n\n<p>Christopher Boerner, Ph.D., CEO of Bristol Myers Squibb, highlighted that this merger fortifies their oncology portfolio, introducing a unique platform and pipeline, promising substantial growth prospects in the coming years. He emphasized the transformative impact of radiopharmaceutical therapeutics in cancer care and the anticipation of bolstering RayzeBio&#8217;s innovative platform through support and expedited development.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em><strong>Ken Song, M.D., President and CEO of RayzeBio,<\/strong> expressed optimism about the collaboration, citing the persistent need for improved solid tumor treatments and the potential of radiopharmaceutical therapeutics in oncology. He highlighted Bristol Myers Squibb&#8217;s established presence and expertise in developing and commercializing oncology treatments as a pivotal factor in this partnership.<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>RayzeBio&#8217;s portfolio includes several programs such as <strong>RYZ101<\/strong> targeting GEP-NETs and ES-SCLC, RYZ801 targeting HCC, and other assets aimed at treating solid tumors. They are in various stages of clinical trials and development, with promising results reported from the ongoing trials.<\/p>\n\n\n\n<p>The acquisition is expected to impact Bristol Myers Squibb&#8217;s earnings per share in 2024 but is considered a strategic move for the company&#8217;s oncology portfolio. Financing for the acquisition is anticipated to primarily come from new debt issuance, leveraging Bristol Myers Squibb&#8217;s financial stability to maintain strong credit ratings and continue investment in growth opportunities, dividends, and share repurchases.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-astrazeneca-to-acquire-gracell-furthering-cell-therapy-ambition-across-oncology-and-autoimmune-diseases\"><span class=\"ez-toc-section\" id=\"AstraZeneca_to_Acquire_Gracell_Furthering_Cell_Therapy_Ambition_Across_Oncology_and_Autoimmune_Diseases\"><\/span><strong>AstraZeneca to Acquire Gracell, Furthering Cell Therapy Ambition Across Oncology and Autoimmune Diseases<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>AstraZeneca <\/strong>has finalized an agreement to acquire <strong>Gracell Biotechnologies Inc.<\/strong>, a global biopharmaceutical company in the clinical stage that focuses on innovative cell therapies for cancer and autoimmune diseases. This move aligns with AstraZeneca&#8217;s aspirations in cell therapy.<\/p>\n\n\n\n<p>The intended acquisition will bolster AstraZeneca&#8217;s expanding portfolio of cell therapies by adding <strong>GC012F<\/strong>, a <strong>novel clinical-stage autologous chimeric antigen receptor T-cell (CAR-T) therapy<\/strong> utilizing <strong>FasTCAR technology<\/strong>, which targets both <strong>BCMA <\/strong>and <strong>CD19<\/strong>. This therapy holds promise as a potential treatment for multiple myeloma, various hematological malignancies, and autoimmune disorders such as <a href=\"https:\/\/www.delveinsight.com\/report-store\/systemic-lupus-erythematosus-market\"><strong>systemic lupus erythematosus (SLE)<\/strong><\/a>.<\/p>\n\n\n\n<p>Autologous CAR-T involves reprogramming a patient&#8217;s immune T cells to combat cells causing diseases, with its manufacturing process being intricate and time-consuming. Gracell&#8217;s FasTCAR platform significantly streamlines this manufacturing process, improves T cell fitness, and potentially enhances the efficacy of autologous CAR-T therapy for patients. The future scope of this technology might extend to addressing rare diseases.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em><strong>Susan Galbraith, Executive Vice President of Oncology R&amp;D at AstraZeneca, stated, <\/strong>&#8220;The proposed acquisition of Gracell will complement AstraZeneca\u2019s current capabilities and previous investments in cell therapy, where we&#8217;ve made headway in CAR-T and T-cell receptor therapies (TCR-Ts) for solid tumors. GC012F will expedite our strategy in cell therapy for blood-related disorders, aiming to deliver a potential leading treatment using an innovative manufacturing process. Additionally, we aim to explore cell therapy&#8217;s potential in resetting the immune response for autoimmune diseases.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em><strong>Dr. William Cao, the founder, Chairman, and CEO of Gracell, expressed, &#8220;<\/strong>We are eager to collaborate with AstraZeneca to fast-track our mutual objective of making groundbreaking cell therapies available to more patients grappling with debilitating illnesses. By pooling our expertise and resources, we can unlock new avenues in utilizing the Gracell FasTCAR manufacturing platform. We believe this platform has the potential to optimize engineered T cells&#8217; therapeutic characteristics, paving the way for the next generation of autologous cell therapies.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>Post-acquisition, Gracell will function as a wholly owned subsidiary of AstraZeneca, maintaining its operations in both China and the United States.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-innovent-dosed-first-participant-in-phase-3-clinical-study-glory-2-of-mazdutide-ibi362-higher-dose-9-mg-in-chinese-adults-with-obesity-nbsp\"><span class=\"ez-toc-section\" id=\"Innovent_Dosed_First_Participant_in_Phase_3_Clinical_Study_GLORY-2_of_Mazdutide_IBI362_Higher_Dose_9_mg_in_Chinese_Adults_with_Obesity\"><\/span><strong>Innovent Dosed First Participant in Phase 3 Clinical Study (GLORY-2) of Mazdutide (IBI362) Higher Dose 9 mg in Chinese Adults with Obesity&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On January 1, 2024,<strong> Innovent Biologics, Inc. (Innovent) (HKEX: 01801) <\/strong>reported the successful dosing of the first participant in the <strong>Phase 3 clinical trial (GLORY-2)<\/strong>. This trial evaluates the higher <strong>9 mg dosage of mazdutide (Innovent R&amp;D Code: IBI362)<\/strong>, a dual agonist targeting the <strong>glucagon-like peptide 1 receptor (GLP-1R)<\/strong> and <strong>glucagon receptor (GCGR)<\/strong>, in Chinese adults with obesity. Notably, this marks the fourth extensive Phase 3 clinical study involving mazdutide.<\/p>\n\n\n\n<p>Innovent has secured an exclusive license agreement with <strong>Eli Lilly and Company (Lilly) <\/strong>for the development and potential commercialization of mazdutide, in China. Clinical studies have showcased mazdutide&#8217;s promising effects, including significant weight loss, improved glucose control, reduced waist circumference, lowered blood lipids and pressure, decreased uric acid levels, liver enzyme improvement, decreased liver fat content, and enhanced insulin sensitivity. Presently, four Phase 3 studies are ongoing, evaluating mazdutide&#8217;s impact on Chinese <a href=\"https:\/\/www.delveinsight.com\/report-store\/weight-loss-weight-management-obesity-epidemiology-forecast\"><strong>patients with overweight or obesity<\/strong><\/a> (GLORY-1 and GLORY-2) and those with type 2 diabetes (DREAM-1 and DREAM-2). These trials aim to further substantiate its efficacy in these patient populations.<\/p>\n\n\n\n<p><strong>GLORY-2<\/strong> aims to recruit <strong>450 participants<\/strong> who will be randomly assigned to receive either mazdutide 9 mg treatment or a placebo. The trial&#8217;s primary endpoints focus on evaluating the percentage change in body weight from the study&#8217;s baseline to week 60 and determining the proportion of subjects achieving a body weight reduction of 5% or more from the baseline at week 60. These endpoints serve as key measures to assess the efficacy of mazdutide in <a href=\"https:\/\/www.delveinsight.com\/report-store\/obesity-pipeline-insight\"><strong>managing obesity<\/strong><\/a> over the 60-week trial period.<\/p>\n\n\n\n<p>In a Phase 2 study involving Chinese individuals with obesity (BMI \u2265 30 kg\/m2) documented under trial NCT04904913, mazdutide at a 9mg dose exhibited promising outcomes. Over a 48-week treatment period, mazdutide demonstrated a noteworthy 18.6% placebo-adjusted average reduction in body weight. Additionally, it contributed to reductions in waist circumference, blood pressure, lipid levels, serum uric acid, transaminase, and liver fat content, indicating multiple metabolic benefits for the participants. Mazdutide&#8217;s tolerability was favorable, with an overall safety profile akin to other drugs within the GLP-1 class, and no new safety concerns were identified.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><strong><em>Dr. Lei Qian, Vice President of Clinical Development at Innovent, stated,<\/em><\/strong><em> &#8220;Different dosage regimens of mazdutide are suitable for different groups of people with obesity. Mazdutide 9 mg is specifically developed to meet the weight loss needs of people with moderate to severe obesity with a BMI above 30 kg\/m2 in China. In a phase 2 study, mazdutide 9 mg showed a more than 18% placebo -adjusted weight loss and multiple cardiovascular and metabolic benefits. In addition, mazdutide 9 mg has simple titration steps and a good safety profile. We are hopeful that mazdutide 9 mg will fully demonstrate its powerful efficacy and good safety in the GLORY-2 study, and bringing a more ideal drug treatment option to patients with moderate to severe obesity, whose current recommended treatment is bariatric surgery.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>China possesses the world&#8217;s largest population affected by overweight or obesity, a trend anticipated to escalate further. In 2019, fatalities attributed to overweight and obesity contributed to <strong>11.1% of deaths <\/strong>associated with chronic non-communicable diseases\u2014an alarming rise from <strong>5.7%<\/strong> reported in 1990. This upsurge underlines the escalating health risks posed by obesity-related conditions in China, emphasizing the critical need for effective interventions and management strategies.<\/p>\n\n\n\n<p>Obesity represents a chronic condition demanding sustained management, yet China faces a scarcity of enduringly effective and safe treatments. Globally, several major pharma and biotech companies including Innovent, and others are actively working to develop <a href=\"https:\/\/www.delveinsight.com\/report-store\/weight-loss-weight-management-obesity-market\"><strong>new therapies to treat Obesity<\/strong><\/a>. The anticipated launch of new therapies is expected to immensely improve the lives of the patients affected by obesity.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-zevra-therapeutics-announces-resubmission-of-arimoclomol-new-drug-application-to-the-us-food-and-drug-administration\"><span class=\"ez-toc-section\" id=\"Zevra_Therapeutics_Announces_Resubmission_of_Arimoclomol_New_Drug_Application_to_the_US_Food_and_Drug_Administration\"><\/span><strong>Zevra Therapeutics Announces Resubmission of Arimoclomol New Drug Application to the US Food and Drug Administration<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On December 27, 2023, <strong>Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) <\/strong>announced the resubmission of its <strong>New Drug Application (NDA)<\/strong> for <strong>arimoclomol<\/strong>, an investigational <a href=\"https:\/\/www.delveinsight.com\/report-store\/niemann-pick-type-c-disease-pipeline-insight\"><strong>treatment for Niemann-Pick Disease Type C<\/strong><\/a>, to the <strong>US FDA <\/strong>on <strong>December 22, 2023<\/strong>. Zevra anticipates receiving an acknowledgment letter from the FDA confirming the completeness of the resubmission and establishing the PDUFA date within approximately 30 days, following standard NDA review timelines. Zevra expects the NDA to fall under Class II submission, implying an anticipated FDA review period of approximately six months from the submission date.<\/p>\n\n\n\n<p>Zevra is confident it has addressed the FDA&#8217;s prior concerns outlined in the complete response letter. This was achieved by providing additional evidence supporting the Niemann-Pick Disease Type C Clinical Severity Scale (NPCCSS)<strong> <\/strong>and conducting supplementary studies to further validate the potential mechanism of action. The resubmission incorporates fresh data derived from various sources, including multiple non-clinical studies, comparisons with natural history, real-world data from ongoing early access programs in the U.S. and EU, as well as findings from the four-year open-label extension of the <strong>Phase 2\/3 clinical trial (NCT02612129)<\/strong>. Outcomes from this extended trial indicate that arimoclomol potentially mitigates the long-term progression of NPC.<\/p>\n\n\n\n<p>Arimoclomol underwent assessment in <strong>21 studies<\/strong> encompassing <strong>Phase 1, 2, or 3 clinical trials<\/strong>, examining its safety and efficacy. These trials encompassed over <strong>600 subjects<\/strong>, including those with <strong>Niemann-Pick Disease Type C,<\/strong> other diseases, and healthy individuals. The pivotal efficacy study specifically targeting NPC was the <strong>Phase 2\/3 trial (CT-ORZY-NPC-002)<\/strong>, a double-blind, placebo-controlled trial involving 50 NPC patients to evaluate the effectiveness of arimoclomol.<\/p>\n\n\n\n<p>Zevra has earned several notable designations from regulatory bodies for Arimoclomol. The U.S. FDA granted it <strong>orphan drug designation, Fast Track designation, Breakthrough Therapy designation, and rare pediatric disease designation<\/strong> for NPC. Additionally, the <strong>European Medicines Agency (EMA)<\/strong> bestowed <strong>orphan medicinal product designation<\/strong> for NPC treatment. Zevra proceeded to resubmit the New Drug Application (NDA) to the FDA in December 2023.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThe Zevra team has worked diligently to deliver a high quality and thorough resubmission of the NDA for arimoclomol following multiple interactions with the FDA and after incorporating direction from the agency,\u201d <\/em><strong><em>said Neil McFarlane, President and Chief Executive Officer of Zevra<\/em><\/strong><em>. \u201cWe continue to accelerate our launch preparations in anticipation of FDA approval, and believe we are one step closer to getting arimoclomol into the hands of patients who are seeking a treatment.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cZevra has engaged with the advocacy community, elevating the patient voice throughout arimoclomol\u2019s development process,\u201d said <strong>Daniel Gallo, Ph.D., Zevra\u2019s Senior Vice President of Medical Affairs and Advocacy<\/strong>. \u201cThe advocacy community\u2019s input has been instrumental in building awareness of the need for approved treatments that address the unmet needs of individuals and their caregivers living with this debilitating condition.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>Niemann-Pick Disease Type C is an exceptionally rare and progressive genetic disorder leading to fatal neurological complications. It arises from mutations occurring in the NPC1 or NPC2 genes. These genes encode crucial proteins found within lysosomes, vital compartments responsible for lipid transport and metabolism. Mutations in either gene cause a depletion of NPC1 or NPC2 proteins, disrupting lysosomal function. This disruption leads to the buildup of intracellular lipids, potentially resulting in cell death if left untreated.&nbsp;<\/p>\n\n\n\n<p>As per DelveInsight, the <a href=\"https:\/\/www.delveinsight.com\/report-store\/niemann-pick-disease-epidemiology-forecast\"><strong>diagnosed prevalent cases of Niemann-Pick Disease Type C<\/strong><\/a> were estimated to be 787 in the 7MM in 2022, of which 335 of the accounted cases were estimated to be from the US alone, and these cases are expected to increase in the upcoming years. The Gender-specific diagnosed prevalent cases of Niemann\u2013Pick Disease Type C (NPC) were found to be 354 and 433 cases categorized into Males and Females, respectively, in the 7MM in 2022.<br>Ongoing <a href=\"https:\/\/www.delveinsight.com\/report-store\/niemann-pick-disease-type-c-market\"><strong>clinical trials in Niemann-Pick Disease Type C treatment<\/strong><\/a> by pharma giants such as Zevra Therapeutics and others are poised to significantly alleviate the burden of this condition. The ongoing clinical trials promise novel insights and potential breakthroughs, offering hope for more effective therapies. By exploring innovative approaches and treatments, pharma giants aim to transform the NPC treatment landscape, providing newfound avenues for managing this challenging disorder and improving patients&#8217; quality of life.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Cytokinetics Announces Positive Results From SEQUOIA-HCM, the Pivotal Phase III Clinical Trial of Aficamten in Patients With Obstructive Hypertrophic Cardiomyopathy Cytokinetics, Incorporated released favorable top-line findings from the SEQUOIA-HCM trial (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the crucial Phase III clinical study evaluating aficamten in individuals experiencing symptomatic obstructive [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":26502,"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":[32],"tags":[96,16939,20732,18077,20537,16730,704,1940,1315,349,420,1173,18316,639,18726,5789,21612],"industry":[17225],"therapeutic_areas":[17237,17240,17238],"class_list":["post-26499","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-astrazeneca","tag-autoimmune-diseases","tag-bristol-myers-squibb-2","tag-chiesi-farmaceutici","tag-cytokinetics","tag-epidermolysis-bullosa","tag-fda","tag-food-and-drug-administration","tag-innovent-biologics","tag-latest-pharma-news","tag-news","tag-obesity","tag-obstructive-hypertrophic-cardiomyopathy","tag-pharma-news","tag-rayzebio","tag-recent-pharma-news","tag-zevra-therapeutics","industry-pharmaceutical","therapeutic_areas-dermatology","therapeutic_areas-endocrinology-and-metabolic-disorders","therapeutic_areas-genetic-disorders"],"acf":[],"yoast_head":"<!-- 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href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/span>"]},"tags":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">AstraZeneca<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">autoimmune diseases<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Bristol Myers Squibb<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Chiesi Farmaceutici<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Cytokinetics<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Epidermolysis Bullosa<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">FDA<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Food and Drug Administration<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Innovent Biologics<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Latest pharma news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">obesity<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Obstructive Hypertrophic Cardiomyopathy<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">pharma news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" 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class=\"advgb-post-tax-term\">obesity<\/span>","<span class=\"advgb-post-tax-term\">Obstructive Hypertrophic Cardiomyopathy<\/span>","<span class=\"advgb-post-tax-term\">pharma news<\/span>","<span class=\"advgb-post-tax-term\">RayzeBio<\/span>","<span class=\"advgb-post-tax-term\">recent pharma news<\/span>","<span class=\"advgb-post-tax-term\">Zevra Therapeutics<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 2 years ago","modified":"Updated 2 years ago"},"absolute_dates":{"created":"Posted on Jan 2, 2024","modified":"Updated on May 14, 2024"},"absolute_dates_time":{"created":"Posted on Jan 2, 2024 6:12 pm","modified":"Updated on May 14, 2024 2:16 pm"},"featured_img_caption":"Pharma News for Cytokinetics, Chiesi, AstraZeneca, 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