{"id":18561,"date":"2022-08-23T17:36:11","date_gmt":"2022-08-23T12:06:11","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=18561"},"modified":"2022-08-23T17:42:56","modified_gmt":"2022-08-23T12:12:56","slug":"pharma-news-for-cidara-gilead-axsome","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-cidara-gilead-axsome","title":{"rendered":"EMA to review Cidara Therapeutics\u2019 Rezafungin; EU Approves Gilead Sciences\u2019 Sunlenca; FDA Approves Axsome\u2019s Auvelity; EU Marketing Authorisation to Oncopeptides\u2019s Pepaxti; Merck Signs $ 3.5 B Deal with Orna; FDA to review AstraZeneca and Merck\u2019s Lynparza; FDA Approval to Bluebird\u2019s Zynteglo; FDA Decision Date for GSK\u2019s Momelotinib"},"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-69fea93b0276d\" 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-69fea93b0276d\"  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-cidara-gilead-axsome\/#EU_Regulator_Starts_its_Review_of_Cidara_Therapeutics_Candidiasis_Therapy_Rezafungin\" >EU Regulator Starts its Review of Cidara Therapeutics\u2019 Candidiasis Therapy Rezafungin<\/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-cidara-gilead-axsome\/#EU_Approves_Gilead_Sciences_HIV_Therapy_Sunlenca\" >EU Approves Gilead Sciences\u2019 HIV Therapy Sunlenca<\/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-cidara-gilead-axsome\/#Merck_Signs_USD_35_Billion_Deal_with_Orna_Therapeutics\" >Merck Signs USD 3.5 Billion Deal with Orna Therapeutics<\/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-cidara-gilead-axsome\/#FDA_Grants_Swift_Review_to_AstraZeneca_and_Mercks_Lynparza\" >FDA Grants Swift Review to AstraZeneca and Merck\u2019s Lynparza&nbsp;<\/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-cidara-gilead-axsome\/#FDA_Approves_Axsomes_Depression_Therapy_Auvelity\" >FDA Approves Axsome\u2019s Depression Therapy Auvelity<\/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-cidara-gilead-axsome\/#European_Commission_Approves_Oncopeptides_Pepaxti_in_Combination_with_Dexamethasone_for_Multiple_Myeloma\" >European Commission Approves Oncopeptides\u2019 Pepaxti in Combination with Dexamethasone for Multiple Myeloma<\/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\/pharma-news-for-cidara-gilead-axsome\/#Bluebird_Bios_Zynteglo_Becomes_First_Cell-based_Gene_Therapy_to_Approve_in_the_US\" >Bluebird Bio\u2019s Zynteglo Becomes First Cell-based Gene Therapy to Approve in the US<\/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\/pharma-news-for-cidara-gilead-axsome\/#GSK_Gets_June_2023_FDA_Decision_Date_for_Momelotinib\" >GSK Gets June 2023 FDA Decision Date for Momelotinib<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-eu-regulator-starts-its-review-of-cidara-therapeutics-candidiasis-therapy-rezafungin\"><span class=\"ez-toc-section\" id=\"EU_Regulator_Starts_its_Review_of_Cidara_Therapeutics_Candidiasis_Therapy_Rezafungin\"><\/span><strong>EU Regulator Starts its Review of Cidara Therapeutics\u2019 Candidiasis Therapy Rezafungin<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The EU regulator has begun its review of <strong>Cidara Therapeutics\u2019<\/strong> once-weekly antifungal <strong>rezafungin<\/strong>, with a decision expected next year as a new option for serious, invasive candida infections. The application is based on the <strong>ReSTORE trial<\/strong>, which demonstrated that <strong>rezafungin<\/strong>, an echinocandin, was as effective as daily dosing with the decades-old drug caspofungin in severe candidemia and invasive candidiasis. <strong>Rezafungin<\/strong>, if approved, would be the first new <a href=\"https:\/\/www.delveinsight.com\/report-store\/hospital-acquired-candida-infections-epidemiology-forecast\">front-line therapy for severe candida infections<\/a> in well over a decade, providing a much-needed new option for patients who do not respond to current front-line drugs.<\/p>\n\n\n\n<p>The EU filing comes shortly after <strong>Cidara <\/strong>and its US partner for the drug, <strong>Melinta Therapeutics<\/strong>, submitted <strong>rezafungin <\/strong>for FDA approval, with a decision expected in the first quarter of 2023. Melinta paid Cidara <strong>USD 30 million<\/strong> upfront for the drug\u2019s US rights in a deal that could be worth up to <strong>USD 460 million<\/strong> in royalties on sales. <strong>Mundipharma <\/strong>now has commercial rights to the antifungal drug in all markets other than the United States and Japan because of a 2019 agreement that included a <strong>USD 30 million<\/strong> upfront fee, a <strong>USD 9 million<\/strong> equity investment, and up to <strong>USD 529 million<\/strong> in milestone payments and royalties.<\/p>\n\n\n\n<p>Despite current treatments, the mortality rate for patients with invasive candidiasis is still high, reaching up to <strong>40%.<\/strong> Because of this unmet need, Cidara predicts a <strong>USD 400 million<\/strong> market opportunity for rezafungin, which could rise to <strong>USD 750 million<\/strong> if the drug also performs well in the <strong>ReSPECT trial<\/strong>, where it is being used to prevent infections with Candida, Aspergillus, and Pneumocystis species in blood and bone marrow transplant patients.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"EU_Approves_Gilead_Sciences_HIV_Therapy_Sunlenca\"><\/span><strong>EU Approves Gilead Sciences\u2019 HIV Therapy Sunlenca<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>After the FDA rejected it earlier this year, the <strong>European Commission<\/strong> has become the first regulator in the world to approve <strong>Gilead Sciences<\/strong>\u2019 <a href=\"https:\/\/www.delveinsight.com\/report-store\/human-immunodeficiency-virus-hiv-1-infection-pipeline-insight\">therapy for people with multidrug-resistant (MDR) HIV infection<\/a> that only needs to be taken twice a year. <strong>Sunlenca<\/strong>, which is based on the HIV capsid inhibitor <strong>lenacapavir<\/strong>, has been approved in the EU for use as an adjunct to antiretroviral therapy in patients who are unable to achieve viral suppression with current drugs. It is administered as an injection every 6 months following an initial oral dose-loading course.<\/p>\n\n\n\n<p>Once available, it will compete with <strong>ViiV Healthcare&#8217;s Rukobia (fostemsavir),<\/strong> <strong>Gilead\u2019s main HIV competitor<\/strong>, which was approved for MDR HIV in the EU last year and in the US in 2020 but must be taken orally every day. <strong>Rukobia <\/strong>earned <strong>\u00a335 million (USD 41 million)<\/strong> in the first half of 2022 and <strong>\u00a345 million<\/strong> overall in 2021. The FDA rejected <strong>Gilead\u2019s<\/strong> first marketing application for <strong>Sunlenca <\/strong>in February due to manufacturing concerns, specifically the possibility of sub-visible particulate contamination from the borosilicate glass vials that were originally used to produce the drug.<\/p>\n\n\n\n<p>Moreover, <strong>Gilead <\/strong>switched to an aluminosilicate glass vial and refiled the drug in June, and is now hoping for FDA approval by the end of its review period on December 27. <strong>Gilead <\/strong>also plans to expand the use of <strong>lenacapavir <\/strong>into new and larger patient populations, including the general HIV-positive population and people who have had sex with HIV-positive partners for pre-exposure prophylaxis (PrEP).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Merck_Signs_USD_35_Billion_Deal_with_Orna_Therapeutics\"><\/span><strong>Merck Signs USD 3.5 Billion Deal with Orna Therapeutics<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Merck <\/strong>announced a collaboration agreement to discover, develop, and commercialize multiple programs, including vaccines and therapeutics in<strong> infectious disease<\/strong> and <strong>oncology<\/strong>.<\/p>\n\n\n\n<p>Under the terms &amp; conditions of the agreement, Merck will make a payment to <strong>Orna<\/strong> of <strong>$150 million<\/strong>, which will be expensed by Merck itself in the third quarter 2022 and included in <strong>non-GAAP<\/strong> results. Additionally, Orna will be eligible to receive upto <strong>$3.5 billion<\/strong> in development, sales, and regulatory milestones allied with the progress of the multiple vaccine, therapeutic programs, and authorities on any approved drugs derived from the association. Orna will preserve rights to its <strong>oRNA-LNP technology platform<\/strong> and will extend to advance other wholly owned programs in various areas such as <strong>oncology <\/strong>and <strong>genetic disease<\/strong>. Merck will invest <strong>$100 million<\/strong> of equity in Orna&#8217;s recently completed <strong>Series B financing round<\/strong>.<\/p>\n\n\n\n<p>By self-circularization, <strong>Orna&#8217;s proprietary oRNA technology<\/strong> creates <strong>circular RNAs <\/strong>from <strong>linear RNAs<\/strong>. oRNA molecules have been shown to have more excellent stability in vivo than linear mRNA and have the potential to process larger quantities of therapeutic proteins inside the body. Newly synthesized oRNA molecules are more concisely packaged into custom lipid nanoparticles, which Orna has engineered to target critical tissues in the body.&nbsp;<\/p>\n\n\n\n<p>Preclinical data, including the presentations at the <strong>2022 American Society of Gene &amp; Cell Therapy Annual Meeting<\/strong>, have showed the potential of oRNA expression and delivery as an approach for further development in multiple areas, including <strong>vaccines <\/strong>and <strong>oncology therapeutics<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Grants_Swift_Review_to_AstraZeneca_and_Mercks_Lynparza\"><\/span><strong>FDA Grants Swift Review to AstraZeneca and Merck\u2019s Lynparza&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>AstraZeneca <\/strong>and <strong>Merck &amp; Co\u2019s PARP inhibitor Lynparza <\/strong>is previously in use to treat <a href=\"https:\/\/www.delveinsight.com\/report-store\/prostate-cancer-market-insight\"><strong>prostate cancer<\/strong><\/a> associated with a specific genetic mutation. However, it could be broadened if the FDA approves a new marketing application.<\/p>\n\n\n\n<p>The US regulator has initiated a priority review of Lynparza in combination with <strong>abiraterone <\/strong>and <strong>prednisone\/prednisolone<\/strong> as a first-line treatment for <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-castration-resistant-prostate-cancer-mcrpc-market\"><strong>metastatic castration-resistant prostate cancer<\/strong><\/a> based on the results of the PROpel trial.<\/p>\n\n\n\n<p>The study included an all-comer population of men with mCRPC showcased that <strong>Lynparza <\/strong>plus <strong>Johnson &amp; Johnson\u2019s hormonal therapy Zytiga<\/strong> reduced the risk of disease progression or death by <strong>34 per cent<\/strong> versus Zytiga alone, with radiographic progression-free survival of <strong>24.8 months<\/strong> and <strong>16.6 months<\/strong>, respectively.<\/p>\n\n\n\n<p>Lynparza was approved in <strong>2020 <\/strong>as second-line therapy for <strong>homologous recombination repair (HRR)<\/strong> <strong>gene-mutated mCRPC<\/strong> last year. However, extending its label to include <strong>non-HRR<\/strong> patients in the frontline setting would increase the number of patients that are eligible for the treatment.<\/p>\n\n\n\n<p>The drug was first approved in <strong>2014<\/strong>, and is used for various indications across <a href=\"https:\/\/www.delveinsight.com\/report-store\/ovarian-cancer-market\"><strong>ovarian cancer<\/strong><\/a><strong>, <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/inflammatory-breast-cancer-market\"><strong>breast cancer<\/strong><\/a><strong>, <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/fallopian-tube-cancer-market\"><strong>fallopian tube cancer<\/strong><\/a><strong>, <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/peritoneal-cancer-pipeline-insight\"><strong>peritoneal cancer<\/strong><\/a><strong> <\/strong>and <a href=\"https:\/\/www.delveinsight.com\/report-store\/pancreatic-cancer-market\"><strong>pancreatic cancer<\/strong><\/a>. It remains one of AstraZeneca&#8217;s fastest-growing oncology therapies, with sales rising <strong>18 per cent<\/strong> to almost <strong>$1.3 billion<\/strong> in the first half of this year.<\/p>\n\n\n\n<p>The priority review indicates that the FDA targets to complete its application assessment within <strong>6 months<\/strong>, and according to AstraZeneca, that should happen before the end of the year.<\/p>\n\n\n\n<p><a href=\"https:\/\/www.delveinsight.com\/report-store\/prostate-cancer-epidemiology-forecast\"><strong>Prostate cancer<\/strong><\/a> is one of the most commonly diagnosed cancer in men, and despite an increase in the number of available treatments for men with metastatic castration-resistant prostate cancer, <strong>5 year survival<\/strong> remains stubbornly low at around <strong>15 per cent<\/strong>. In the United States, prostate cancer is projected to cause around <strong>35,000 deaths<\/strong> in the year <strong>2022<\/strong>.<\/p>\n\n\n\n<p>The new indication would also extend Lynparza\u2019s lead in prostate cancer over rival PARP inhibitors like <strong>GSK\u2019s Zejula, Clovis Oncology\u2019s Rubraca<\/strong>, and <strong>Pfizer\u2019s Talzenna<\/strong>.<\/p>\n\n\n\n<p><strong>Rubraca <\/strong>was approved in the year <strong>2020 <\/strong>for <strong>BRCA1\/2 mutated mCRPC<\/strong> and is in two phases III trials to extend its label. These include the <strong>CASPAR study<\/strong> of the drug in combination with <strong>Pfizer\/Astellas\u2019 Xtandi<\/strong>, which consists of an all-comer mCRPC population whose tumors have become resistant to androgen-reducing first-line medicines.<\/p>\n\n\n\n<p><strong>GSK\u2019s Zejula<\/strong> recently showed that it improved <strong>rPFS<\/strong> in patients with <strong>newly-diagnosed mCRPC<\/strong> when given alongside <strong>Zytiga <\/strong>and <strong>prednisone <\/strong>in the <strong>MAGNITUDE <\/strong>trial. Still, its benefits were confined to patients with <strong>homologous recombination repair mutations<\/strong> only.<\/p>\n\n\n\n<p>Meanwhile, <strong>Pfizer\u2019s Talzenna <\/strong>has been paired with <strong>Xtandi <\/strong>in <strong>phase III TALAPRO-II<\/strong> <strong>trial<\/strong>, in patients suffering with and without homologous recombination repair mutations, with results awaited later this month.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Approves_Axsomes_Depression_Therapy_Auvelity\"><\/span><strong>FDA Approves Axsome\u2019s Depression Therapy Auvelity<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Axsome Therapeutics has updated that the US FDA has approved AUVELITYTM (dextromethorphan HBr -bupropion HCl) extended-release tablets for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/major-depressive-disorder-market\"><strong>treatment of the Major Depressive Disorder (MDD)<\/strong><\/a> in adults.&nbsp;<\/p>\n\n\n\n<p>AUVELITY is the first, only approved oral N-methyl D-aspartate (NMDA) receptor antagonist medicine to treat Major Depressive Disorder. The therapy has a statistically significant antidepressant efficacy compared to a placebo starting at one week. The rapid antidepressant effects of AUVELITY have been sustained at all subsequent time points. AUVELITY uses the first new oral mechanism of action in more than 60 years for MDD.&nbsp;<\/p>\n\n\n\n<p>In the clinical trials, AUVELITY was studied in a GEMINI placebo-controlled study in more than 1,100 patients with depression. In the study, AUVELITY demonstrated superior results compared to placebo in improving depressive symptoms as measured by the change in the Montgomery-\u00c5sberg Depression Rating Scale (MADRS) total score at Week 6. AUVELITY works on the NMDA receptor, an ionotropic glutamate receptor, and the sigma-1 receptor in the brain via its dextromethorphan component.<\/p>\n\n\n\n<p>Based on preliminary clinical data, in March 2019, the FDA granted Breakthrough Therapy designation for AUVELITY to <strong>treat Major Depressive Disorder<\/strong>. Additionally, the therapy was evaluated by the FDA under Priority Review. As per the initial updates, AUVELITY is expected to be commercially available in the U.S. in the fourth quarter of 2022.&nbsp;<\/p>\n\n\n\n<p>Major Depressive Disorder is a debilitating, chronic, biologically-based disorder that results in a low mood and energy and is often accompanied by other emotional and physical symptoms. As per WHO, MDD affects 322 million people globally, representing an 18.4% increase in the number of <a href=\"https:\/\/www.delveinsight.com\/report-store\/major-depressive-disorder-epidemiology-forecast\"><strong>people living with Major Depressive Disorder<\/strong><\/a> between 2005 and 2015. According to the U.S. Department of Health and Human Services, an estimated 21 million U.S. adults experience Major Depressive Disorder each year. Apart from Axsome, several key companies such as <strong>Allergan <\/strong>(Cariprazine), <strong>SAGE Therapeutics <\/strong>(SAGE-217), <strong>Seelos Therapeutics <\/strong>(SLS-002), <strong>Clexio Biosciences<\/strong> (CLE-100), and others are evaluating their <a href=\"https:\/\/www.delveinsight.com\/report-store\/major-depressive-disorder-pipeline-insight\"><strong>Major Depressive Disorder therapies<\/strong><\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"European_Commission_Approves_Oncopeptides_Pepaxti_in_Combination_with_Dexamethasone_for_Multiple_Myeloma\"><\/span><strong>European Commission Approves Oncopeptides\u2019 Pepaxti in Combination with Dexamethasone for Multiple Myeloma<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Oncopeptides AB has announced that the European Commission has granted marketing authorization to its therapy Pepaxti\u00ae (melphalan flufenamide, also called melflufen) in combination with dexamethasone, for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/multiple-myeloma-market\"><strong>treatment of multiple myeloma in adults<\/strong><\/a>. The marketing authorization is valid in all EU member states and the European Economic Area (EEA), including Iceland, Lichtenstein, and Norway. Oncopeptides is looking forward to launching the therapy in Germany in Q4, 2022, ahead of an EU-wide rollout.<\/p>\n\n\n\n<p>Pepaxti (melphalan flufenamide, also called melflufen) is a lipophilic peptide conjugated alkylating drug that rapidly and selectively delivers cytotoxic agents into tumor cells. The drug is composed of a di-peptide and an alkylating moiety. The therapy is approved only for patients who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody. The drug is also approved to treat patients who have demonstrated disease progression on or after the last therapy.&nbsp;<\/p>\n\n\n\n<p>EU approval of Pepaxti was based on the key findings observed in the Phase II HORIZON study and the randomized controlled Phase III OCEAN study. On July 20, 2022, the FDA announced a public advisory meeting of the Oncologic Drugs Advisory Committee on September 22, 2022, to discuss the benefit\/risk of melphalan flufenamide.&nbsp;<\/p>\n\n\n\n<p>Multiple Myeloma is one of the most common hematologic malignancies that originates in plasma cells, a type of white blood cell, and accounts for approximately 1-2% of all new cancer cases. The <a href=\"https:\/\/www.delveinsight.com\/report-store\/multiple-myeloma-epidemiology-forecast-insight\"><strong>global incidence rate of Multiple Myeloma<\/strong><\/a> is observed to be 1.7 per 100,000. According to DelveInsight&#8217;s assessment, among the EU-5 countries, in 2020, Germany registered the highest number of <a href=\"https:\/\/www.delveinsight.com\/report-store\/multiple-myeloma-epidemiology-forecast-insight\"><strong>cases of Multiple myeloma<\/strong><\/a> with 7,600 cases.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Bluebird_Bios_Zynteglo_Becomes_First_Cell-based_Gene_Therapy_to_Approve_in_the_US\"><\/span><strong>Bluebird Bio\u2019s Zynteglo Becomes First Cell-based Gene Therapy to Approve in the US<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Bluebird Bio\u2019s Zynteglo became not only the first but the most expensive gene therapy after it is by the US FDA on Wednesday. Also known as <strong>Beti-cel<\/strong>, Zynteglo is a one-time gene therapy that is custom-designed to <a href=\"https:\/\/www.delveinsight.com\/report-store\/beta-thalassemia-pipeline-insight\"><strong>treat beta-thalassemia in adult and pediatric patients<\/strong><\/a>. Majorly those who require blood transfusions at regular intervals.&nbsp;<\/p>\n\n\n\n<p>The gene therapy nearly took <strong>10 years<\/strong> of development. Zynteglo is launched at a price tag of approximately <strong>USD 2.8 million<\/strong>. The therapy offers advanced treatment by providing a reliable alternative to regular <a href=\"https:\/\/www.delveinsight.com\/report-store\/transfusion-dependent-thalassaemia-market\"><strong>red blood cell transfusions<\/strong><\/a> and iron chelation. Beta-thalassemia is a rare disorder causing hypoxia in patients&#8217; bodies, commonly leading to liver and heart complexity.&nbsp;<\/p>\n\n\n\n<p>The drug is expected to face some complications from insurers due to its high pricing. Bluebird has been pitching Zynteglo in order to secure a one-time therapy that can comply with the transfusion demands. It\u2019ll ultimately aid in saving patients over a long period of time.&nbsp;<\/p>\n\n\n\n<p>The average cost for a single transfusion is approximately <strong>6.4 million USD<\/strong>. Since the treatment comes with a high cost, up to <strong>80% of that payment will be refunded<\/strong> if a patient does not achieve transfusion independence. The launch of the treatment is expected in the fourth quarter. Almost negligible revenue is expected till the end of 2022 since the treatment cycle is approximately<strong> 70 to 90 days,<\/strong> starting from the first cell collection to the final transfusion.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"GSK_Gets_June_2023_FDA_Decision_Date_for_Momelotinib\"><\/span><strong>GSK Gets June 2023 FDA Decision Date for Momelotinib<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>US Food and Drug Administration (FDA) approved GlaxoSmithKline Plc\u2019s<strong> New Drug Application (NDA)<\/strong> for Momelotinib. The drug comprises a differentiated mechanism of action for <a href=\"https:\/\/www.delveinsight.com\/report-store\/myelofibrosis-market\"><strong>treating anemic patients with myelofibrosis<\/strong><\/a>. As per the reports US FDA assigned <strong>16 June 2023<\/strong> for Prescription Drug User Fee Act Action.&nbsp;<\/p>\n\n\n\n<p>The approval of NDA is based on the outcomes of major <strong>Phase III <\/strong>trials. The Momentum trial of the drug Momelotinib passed all the requirements, including primary and key secondary endpoints, which majorly comprised Splenic Response Rate (SRR), Transfusion Independence (TI) rate, and Total Symptom Score (TSS). The final analysis data of the trial for the drug was preset at the <strong>2022 American Society of Clinical Oncology Annual Meeting and the European Hematology Association 2022 Hybrid Congress<\/strong>.<\/p>\n\n\n\n<p>The final approval of the market for Momelotinib is yet to be announced.&nbsp; Momelotinib was initially developed by <strong>Sierra Oncology, Inc.,<\/strong> which GlaxoSmithKline Plc further occupied in July 2022. Myelofibrosis is a rare condition causing hematologic cancer majorly due to dysregulated JAK-signal transducer and activator of transcription protein signaling. The <a href=\"https:\/\/www.delveinsight.com\/report-store\/myelofibrosis-epidemiology-forecast\"><strong>major symptoms of myelofibrosis<\/strong><\/a> include splenomegaly and progressive anemia.&nbsp;<\/p>\n\n\n\n<p>Myelofibrosis is known to affect <strong>approx 20,000 patients <\/strong>in the US, including which <strong>40% of the patients<\/strong> are <a href=\"https:\/\/www.delveinsight.com\/report-store\/anemia-in-elderly-epidemiology-forecast\"><strong>pre-diagnosed with anemia<\/strong><\/a>, and the remaining patients develop anemia gradually. The major cause behind 30% of patients discontinuing the treatment is the lack of enough blood inside the body. The patients might also need to undergo multiple transfusions as a part of treatment.&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>EU Regulator Starts its Review of Cidara Therapeutics\u2019 Candidiasis Therapy Rezafungin The EU regulator has begun its review of Cidara Therapeutics\u2019 once-weekly antifungal rezafungin, with a decision expected next year as a new option for serious, invasive candida infections. The application is based on the ReSTORE trial, which demonstrated that rezafungin, an echinocandin, was as [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":18564,"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":[1106,19661,19662,298,16942,19663,410,5005,420,639,498],"industry":[17225],"therapeutic_areas":[17233,17231,17245,17228],"class_list":["post-18561","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-bone-marrow-transplant","tag-candida-infections","tag-candidiasis","tag-hiv-infection","tag-major-depressive-disorder","tag-major-depressive-disorder-mdd","tag-multiple-myeloma","tag-myelofibrosis","tag-news","tag-pharma-news","tag-prostate-cancer","industry-pharmaceutical","therapeutic_areas-hematological-disorders","therapeutic_areas-infectious-diseases","therapeutic_areas-neurology","therapeutic_areas-oncology"],"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\">Bone Marrow Transplant<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">candida infections<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">candidiasis<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">HIV infection<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Major Depressive Disorder<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Major Depressive Disorder 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class=\"advgb-post-tax-term\">Multiple Myeloma<\/span>","<span class=\"advgb-post-tax-term\">Myelofibrosis<\/span>","<span class=\"advgb-post-tax-term\">news<\/span>","<span class=\"advgb-post-tax-term\">pharma news<\/span>","<span class=\"advgb-post-tax-term\">Prostate Cancer<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 4 years ago","modified":"Updated 4 years ago"},"absolute_dates":{"created":"Posted on Aug 23, 2022","modified":"Updated on Aug 23, 2022"},"absolute_dates_time":{"created":"Posted on Aug 23, 2022 5:36 pm","modified":"Updated on Aug 23, 2022 5:42 pm"},"featured_img_caption":"Pharma News for Cidara, Merck, 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