{"id":19001,"date":"2022-09-20T20:28:41","date_gmt":"2022-09-20T14:58:41","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=19001"},"modified":"2022-09-21T10:30:32","modified_gmt":"2022-09-21T05:00:32","slug":"pharma-news-for-akero-chiesi-pfizer","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-akero-chiesi-pfizer","title":{"rendered":"AstraZeneca\u2019s Danicopan Trial; CHMP Recommends Sanofi\/AstraZeneca\u2019s nirsevimab; Akero\u2019s NASH Drug Trial; FDA Grants Orphan Drug Status to SY-5609; BMS\u2019s Opdivo Trial Results; Pfizer to File for FDA Approval for Meningitis Vaccine; EMA Orphan Drug Designation to CAN-2409; FDA Starts Priority Review of Chiesi \u2018s velmanase alfa"},"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-6a113f3556838\" 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-6a113f3556838\"  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-akero-chiesi-pfizer\/#AstraZenecas_Danicopan_Shows_Positive_Results_in_Phase_III_Trial\" >AstraZeneca\u2019s Danicopan Shows Positive Results in Phase III Trial<\/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-akero-chiesi-pfizer\/#CHMP_Recommends_SanofiAstraZeneca_Antibody_for_RSV_Prevention\" >CHMP Recommends Sanofi\/AstraZeneca Antibody for RSV Prevention<\/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-akero-chiesi-pfizer\/#EMA_Grants_Orphan_Drug_Designation_to_CAN-2409_for_Glioma\" >EMA Grants Orphan Drug Designation to CAN-2409 for Glioma<\/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-akero-chiesi-pfizer\/#FDA_Starts_Priority_Review_of_Chiesi_%E2%80%98s_velmanase_alfa\" >FDA Starts Priority Review of Chiesi \u2018s velmanase alfa<\/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-akero-chiesi-pfizer\/#Akeros_NASH_Drug_Hits_Targets_in_Phase_IIb_Trial\" >Akero\u2019s NASH Drug Hits Targets in Phase IIb Trial<\/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-akero-chiesi-pfizer\/#FDA_Grants_Orphan_Drug_Status_to_SY-5609_for_Pancreatic_Cancer\" >FDA Grants Orphan Drug Status to SY-5609 for Pancreatic Cancer<\/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-akero-chiesi-pfizer\/#Bristol-Myers_Squibbs_Opdivo_Shows_Promising_Results_in_Phase_III_Melanoma_Trial\" >Bristol-Myers Squibb\u2019s Opdivo Shows Promising Results in Phase III Melanoma Trial<\/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-akero-chiesi-pfizer\/#Pfizer_to_File_for_FDA_Approval_for_Meningitis_Vaccine_After_Positive_Phase_III_Result\" >Pfizer to File for FDA Approval for Meningitis Vaccine After Positive Phase III Result<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-astrazeneca-s-danicopan-shows-positive-results-in-phase-iii-trial\"><span class=\"ez-toc-section\" id=\"AstraZenecas_Danicopan_Shows_Positive_Results_in_Phase_III_Trial\"><\/span><strong>AstraZeneca\u2019s Danicopan Shows Positive Results in Phase III Trial<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Danicopan<\/strong>, an oral Factor D inhibitor developed by <strong>AstraZeneca<\/strong>, was expected to fail a phase II trial in rare kidney disease in 2020, but a new readout could revive the drug. <strong>Danicopan (ALXN2040)<\/strong> has demonstrated efficacy as an adjunct treatment for <a href=\"https:\/\/www.delveinsight.com\/report-store\/paroxysmal-nocturnal-hemoglobinuria-market\">patients with paroxysmal nocturnal hemoglobinuria (PNH)<\/a> who have extravascular hemolysis (EVH) &#8211; the breakdown of red blood cells in the spleen, bone marrow, or liver. The drug is being developed for use in PNH in combination with <strong>Alexion&#8217;s <\/strong>established C5 inhibitor therapies <strong>Soliris (eculizumab) and Ultomiris (ravulizumab)<\/strong>, as well as for eye disease geographic atrophy.<\/p>\n\n\n\n<p>It was discontinued for C3 glomerulopathy (C3G) in 2020 after failing a Phase II trial. <strong>ALXN2050<\/strong>, a follow-up Factor D inhibitor being developed by <strong>AstraZeneca\/Alexion<\/strong> for C3G, as well as PNH and generalized myasthenia gravis, another disease treated with <strong>Ultomiris<\/strong> and <strong>Soliris<\/strong>.<\/p>\n\n\n\n<p>People with PNH develop anemia as a result of blood cell destruction, as well as potentially fatal blood clots. Although some patients can live for decades with only minor symptoms, the median survival time after diagnosis is 10 years. Interim results from the<strong> ALPHA trial<\/strong> showed that adding danicopan to the C5 inhibitors resulted in a significant improvement in hemoglobin levels over a placebo after 12 weeks of treatment.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\"><p>\u201cThese are the first positive phase III results for an oral factor D inhibitor and demonstrate the potential for danicopan add-on therapy to improve signs and symptoms and reduce the need for transfusions for the limited proportion of people living with PNH who experience clinically significant EVH,\u201d said <strong>Alexion\u2019s chief executive, Marc Dunoyer.<\/strong><\/p><\/blockquote>\n\n\n\n<p>AZ stated that it plans to submit marketing applications for <strong>danicopan<\/strong> in <a href=\"https:\/\/www.delveinsight.com\/report-store\/paroxysmal-nocturnal-hemoglobinuria-epidemiology-forecast\">PNH patients<\/a> with EVH in the coming months. While this is most likely a small indication, the positive outcome bodes well for <strong>danicopan<\/strong> and<strong> ALXN-2050<\/strong> in other applications with larger patient populations.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"CHMP_Recommends_SanofiAstraZeneca_Antibody_for_RSV_Prevention\"><\/span><strong>CHMP Recommends Sanofi\/AstraZeneca Antibody for RSV Prevention<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Sanofi<\/strong> and <strong>AstraZeneca <\/strong>are preparing to submit <strong>nirsevimab<\/strong>, a long-acting antibody for the protection of newborns and infants against respiratory syncytial virus (RSV) infections, to the European Union. The EMA&#8217;s human medicines committee, known as the CHMP, has recommended approval of a single dose of the antibody, known as <strong>Beyfortus<\/strong>, to prevent lower respiratory tract infections caused by RSV. Beyfortus, if approved, would be the first and only single-dose, passive immunization for a broad infant population, including those born healthy, at term or preterm, or with specific health conditions, according to a joint statement from <strong>AstraZeneca <\/strong>and <strong>Sanofi<\/strong>.<\/p>\n\n\n\n<p><strong>Synagis (palivizumab)<\/strong> by AstraZeneca is currently the only approved drug in Europe to provide passive RSV prophylaxis, but it must be administered monthly, whereas nirsevimab can provide protection throughout the RSV season. <strong>Sobi <\/strong>is the company that sells <strong>Synagis <\/strong>in the United States.<\/p>\n\n\n\n<p>Despite losing patent protection, the former blockbuster is still selling well, with AstraZeneca earning <strong>USD 410 million<\/strong> from the drug last year. However, sales are expected to fall sharply once <strong>Beyfortus, <\/strong>and <a href=\"https:\/\/www.delveinsight.com\/report-store\/respiratory-syncytial-virus-rsv-pipeline-insight\">RSV vaccines<\/a> hit the market. Pfizer is currently leading the race to bring an RSV vaccine to market for use by expectant mothers, which would transfer protection to newborns and infants, with phase III results expected next year.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\"><p>\u201cThe positive CHMP opinion is one of the most significant public health achievements in RSV in decades and has the potential to alleviate the enormous physical and emotional burden that RSV can place on families and healthcare systems,\u201d said <strong>Jean-Fran\u00e7ois Toussaint, Sanofi\u2019s head of vaccines R&amp;D.<\/strong><\/p><\/blockquote>\n\n\n\n<p>Sanofi invested <strong>USD 645 million<\/strong> in the <strong>nirsevimab <\/strong>program in 2017, paying for marketing rights to the antibody while AstraZeneca continued to develop and manufacture it. <strong>Sobi <\/strong>is also interested in the new drug as part of its 2019 Synagis agreement with AstraZeneca.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"EMA_Grants_Orphan_Drug_Designation_to_CAN-2409_for_Glioma\"><\/span><strong>EMA Grants Orphan Drug Designation to CAN-2409 for Glioma<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Candel Therapeutics<\/strong> has announced that the <strong>European Medicines Agency Committee<\/strong> for <strong>Orphan Medical Products<\/strong> issued a positive opinion on the company\u2019s application for orphan drug designation for <strong>CAN-2409<\/strong> treatment of <a href=\"https:\/\/www.delveinsight.com\/report-store\/glioma-market\"><strong>Glioma<\/strong><\/a>. CAN-2409 is a genetically modified adenovirus and the company\u2019s most advanced investigational therapy which is currently being evaluated in multiple <strong>phase II<\/strong> and <strong>phase III<\/strong> clinical trials for lung cancer,<a href=\"https:\/\/www.delveinsight.com\/report-store\/brain-cancer-market\"><strong> brain cancer<\/strong><\/a>, <a href=\"https:\/\/www.delveinsight.com\/report-store\/pancreatic-cancer-market\"><strong>pancreatic cancer<\/strong><\/a>, and <a href=\"https:\/\/www.delveinsight.com\/report-store\/prostate-cancer-market-insight\"><strong>prostate cancer<\/strong><\/a>.<\/p>\n\n\n\n<p>The orphan drug designation follows the U.S. FDA fast-track designation, which was granted in <strong>June 2021<\/strong> for CAN-2409 combined with <strong>valacyclovir <\/strong>following standard of care treatment in newly diagnosed <a href=\"https:\/\/www.delveinsight.com\/report-store\/high-grade-glioma-market\"><strong>high-grade Glioma<\/strong><\/a>.<\/p>\n\n\n\n<p>The <strong>European Commission<\/strong> grants orphan drug designation in the European Union based on a positive opinion issued by the <strong>EMA COMP<\/strong>. The EMA\u2019s orphan drug designation is available to companies which are developing treatment and therapies for life-threatening or chronically debilitating conditions that affect no more than <strong>5<\/strong> in<strong> 10,000<\/strong> persons in the European Union. Additionally, there must be sufficient clinical\/non-clinical data to suggest the product candidate may produce clinically relevant results and grounds to indicate that it can provide a significant benefit over any currently authorized products. The designation can provide regulatory and financial incentives, including ten years of marketing exclusivity in the European Union after product approval, protocol assistance from the EMA at reduced price during the product development phase, and access to centralized marketing authorization.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Starts_Priority_Review_of_Chiesi_%E2%80%98s_velmanase_alfa\"><\/span><strong>FDA Starts Priority Review of Chiesi \u2018s velmanase alfa<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Chiesi Global Rare Diseases<\/strong> announced that the<strong> U.S. FDA<\/strong> has accepted the <strong>Biologics License Application<\/strong> and granted <strong>Priority Review designation<\/strong> for <strong>velmanase alfa<\/strong>, the company&#8217;s investigational enzyme replacement therapy for the proposed treatment of <a href=\"https:\/\/www.delveinsight.com\/report-store\/alpha-mannosidosis-market\"><strong>alpha-mannosidosis<\/strong><\/a>.<\/p>\n\n\n\n<p>Alpha-mannosidosis is an ultra-rare genetic disorder that begins in childhood and progresses through adulthood. It is characterized by a deficiency of the enzyme alpha-mannosidase that results in the body&#8217;s cells being unable to break down certain groups of complex sugars properly. The sugar buildup can affect many body parts, organs and systems, including the central nervous system. Effects of the disease vary from person to person and progress over time. Symptoms may change as the patient ages, including <strong>distinctive facial features, recurrent ear and chest infections, hearing loss, muscle weakness, skeletal <\/strong>and <strong>joint abnormalities<\/strong>, and <strong>visual or cognitive abnormalities<\/strong>. Globally, the <strong>alpha-mannosidosis prevalence<\/strong> is approximately <strong>1-9\/1,000,000<\/strong>.<\/p>\n\n\n\n<p>Velmanase alfa is a recombinant form of <strong>human alpha-mannosidase<\/strong> planned to offer natural alpha-mannosidase which is an enzyme that assists with the degradation of <strong>mannose\u2013rich oligosaccharides <\/strong>to prevent their accumulation in various tissues in the body. In 2018, Chiesi Group received marketing authorization from the European Commission for <strong>Lamzede <\/strong>to treat non-neurological manifestations in patients suffering with <strong>mild to moderate alpha\u2011mannosidosis<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Akeros_NASH_Drug_Hits_Targets_in_Phase_IIb_Trial\"><\/span><strong>Akero\u2019s NASH Drug Hits Targets in Phase IIb Trial<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Akero Therapeutics has released topline data from Phase 2b HARMONY study, evaluating the efficacy and safety of its lead product candidate, efruxifermin (EFX), in patients with pre-cirrhotic nonalcoholic steatohepatitis (NASH), fibrosis stage 2 or 3 (F2-F3). EFX is designed to reverse fibrosis, reduce liver fat and inflammation, increase insulin sensitivity, and improve lipoproteins.&nbsp;<\/p>\n\n\n\n<p>Efruxifermin (EFX) is currently being evaluated in the ongoing Phase 2b HARMONY study. Akero\u2019s HARMONY study is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in biopsy-confirmed <a href=\"https:\/\/www.delveinsight.com\/report-store\/nonalcoholic-steatohepatitis-nash-epidemiology-forecast\"><strong>adult patients with pre-cirrhotic NASH<\/strong><\/a>, fibrosis stage 2 or 3. As per the statement issued by Akero Therapeutics, the study met its primary endpoint for both the 50mg and 28mg EFX dose groups, with 41% and 39% of EFX-treated patients, respectively, experiencing at least a one-stage improvement in liver fibrosis with no worsening of NASH by week 24, compared with 20% for the placebo arm. The study also met a key secondary endpoint and achieved NASH resolution without worsening fibrosis.<\/p>\n\n\n\n<p>As per the American Liver Foundation, NAFLD is the most common chronic liver condition in the United States, and 25 percent of adults in the US have NAFLD; out of those, about 20% have NASH (5% of adults in the US). Currently, there is no standard <a href=\"https:\/\/www.delveinsight.com\/report-store\/non-alcoholic-steatohepatitis-nash-pipeline-insight\"><strong>treatment for patients with NASH<\/strong><\/a>. Majorly, NASH is managed with lifestyle changes that are shown to affect its progression. The lifestyle modification includes losing weight, maintaining a healthy diet, or addressing underlying conditions such as hypothyroidism and diabetes. It is observed that if the <a href=\"https:\/\/www.delveinsight.com\/report-store\/nonalcoholic-steatohepatitis-nash-market\"><strong>patient with NASH<\/strong><\/a> also has cirrhosis, the treatment may include medications and possibly surgery. People with NASH who develop liver cancer or liver failure may require a transplant. Akero\u2019s NASH Drug efruxifermin (EFX) raises hope for a better option for the patients affected by NASH.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Grants_Orphan_Drug_Status_to_SY-5609_for_Pancreatic_Cancer\"><\/span><strong>FDA Grants Orphan Drug Status to SY-5609 for Pancreatic Cancer<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Syros Pharmaceuticals has announced that the US FDA has granted orphan drug designation (ODD) to its potential <a href=\"https:\/\/www.delveinsight.com\/report-store\/pancreatic-cancer-pipeline-insight\"><strong>pancreatic cancer therapy<\/strong><\/a>, SY-5609. SY-5609 is a highly selective and potent oral cyclin-dependent kinase 7 (CDK7) inhibitor.&nbsp;<\/p>\n\n\n\n<p>The therapy is currently being evaluated in the Phase 1 trial in combination with chemotherapy to treat <a href=\"https:\/\/www.delveinsight.com\/report-store\/pancreatic-cancer-epidemiology-forecast\"><strong>patients with relapsed metastatic pancreatic cancer<\/strong><\/a> who have progressed following treatment with FOLFIRINOX. Patients were randomized to receive either SY-5609 in combination with gemcitabine or SY-5609 in combination with gemcitabine and nab-paclitaxel, at the approved doses of the combination agents. The study is intended to assess safety and tolerability, as well as efficacy measures such as disease control rate and progression-free survival in patients with pancreatic cancer.<\/p>\n\n\n\n<p>Following the announcement from Syros Pharmaceuticals, David A. Roth, M.D., Chief Medical Officer of Syros, stated, \u201cthis orphan drug designation underscores the urgency of our efforts to develop SY-5609 for <a href=\"https:\/\/www.delveinsight.com\/report-store\/pancreatic-cancer-market\"><strong>patients with pancreatic cancer<\/strong><\/a>, one of the most devastating and difficult to treat malignancies,\u201d. Syros Pharmaceuticals is expected to present the safety and clinical activity data from the safety lead-in portion of the trial in the second half of 2022.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Bristol-Myers_Squibbs_Opdivo_Shows_Promising_Results_in_Phase_III_Melanoma_Trial\"><\/span><strong>Bristol-Myers Squibb\u2019s Opdivo Shows Promising Results in Phase III Melanoma Trial<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Bristol-Myers Squibb indicated that the first analysis of the phase III trial of <strong>Opdivo (nivolumab)<\/strong> showed better results with an increased response rate. The toxicity profile was also analyzed to be less than the preexisting <a href=\"https:\/\/www.delveinsight.com\/report-store\/melanoma-market\">chemotherapy techniques for metastatic melanoma<\/a>. The study can potentially bring new therapies to encourage and aid the human body in fighting against cancer cells. The results of the study showed that<strong> almost 32% of the patient&#8217;s tumor cells were shrunk among the 11%<\/strong> population of chemotherapy patients. <strong>The drug showed a longer t1\/2, and the response persisted for almost six months and longer, as compared to chemotherapy response that lasts upto 3.6 months.<\/strong>&nbsp;<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\"><p>\u201cI was very nicely surprised,\u201d said J<strong>effrey Weber of the Moffitt Cancer Center<\/strong> in Florida. \u201cA 32% response rate with the majority staying in remission past six months is probably going to turn into a very impressive level of survival,\u201d he stated. \u201cI hope this is the death knell for chemotherapy in melanoma.\u201d The drug Opdivo (nivolumab) is designed for<a href=\"https:\/\/www.delveinsight.com\/report-store\/programmed-death-ligand-1-pd-l1-non-small-cell-lung-cancer-nsclc-market\"><strong> PD-1and PD-L1,<\/strong><\/a><strong> <\/strong>which act as a source by which tumor cells evade the body\u2019s immune system.\u00a0<\/p><\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Pfizer_to_File_for_FDA_Approval_for_Meningitis_Vaccine_After_Positive_Phase_III_Result\"><\/span><strong>Pfizer to File for FDA Approval for Meningitis Vaccine After Positive Phase III Result<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>After a successful phase III trial, Pfizer is all set to file for <strong>FDA approval for the new MenABCWY vaccine. <\/strong>The drug was assessed for its safety, tolerability, and immunogenicity and showed positive results after finishing the trial. The <strong>phase III trial comprised around 10 candidates each in the 25 years age group. <\/strong>The vaccine is developed against <a href=\"https:\/\/www.delveinsight.com\/report-store\/meningococcal-meningitis-market\"><strong>invasive meningococcal disease<\/strong><\/a>: serogroups A, B, C, W, and Y. MenACWY and MenB vaccines are the current two preexisting vaccines in the market to protect against all five serogroups. The results of MenABCWY showed increased immunity responses in non-vaccinated groups, i.e., up t<strong>o \u22654-fold higher than pre-existing<\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/meningococcal-meningitis-market\"><strong>vaccines for meningococcal disease<\/strong><\/a>. <\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\"><p>\u201cWe are very pleased with these positive Phase III data, which are the first for a MenABCWY vaccine candidate,\u201d said <strong>Annaliesa Anderson, Ph.D., Senior Vice President<\/strong>, and <strong>Chief Scientific Officer, Vaccine Research and Development, Pfizer<\/strong>. \u201cA pentavalent vaccine can help simplify the complex meningococcal vaccination schedule in the U.S. and improve vaccine coverage. Our goal is to help ensure as many adolescents and young adults as possible are protected against this devastating disease.\u201d<\/p><\/blockquote>\n\n\n\n<p><strong>Meningococcal disease<\/strong> is a lesser common but chronic disease that can result in death within 24 hours. Those who successfully survive the disease are left with lifelong impairments. Amongst five serotypes,<strong> B-serotype <\/strong>is accountable for causing maximum deaths in adolescents and young adults in the U.S. and Europe.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>AstraZeneca\u2019s Danicopan Shows Positive Results in Phase III Trial Danicopan, an oral Factor D inhibitor developed by AstraZeneca, was expected to fail a phase II trial in rare kidney disease in 2020, but a new readout could revive the drug. Danicopan (ALXN2040) has demonstrated efficacy as an adjunct treatment for patients with paroxysmal nocturnal hemoglobinuria 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