{"id":708195,"date":"2020-08-07T11:30:00","date_gmt":"2020-08-07T11:30:00","guid":{"rendered":"https:\/\/www.pm360online.com\/?guid=ee8ea30e3b498defe331014dae17891b"},"modified":"2020-08-07T11:30:00","modified_gmt":"2020-08-07T11:30:00","slug":"fda-accepts-biogens-aducanumab-biologics-license-application-for-alzheimers-disease-with-priority-review-2","status":"publish","type":"post","link":"https:\/\/www.pm360online.com\/fda-accepts-biogens-aducanumab-biologics-license-application-for-alzheimers-disease-with-priority-review-2\/","title":{"rendered":"FDA Accepts Biogen&rsquo;s Aducanumab Biologics License Application for Alzheimer&#8217;s Disease with Priority Review"},"content":{"rendered":"<p><![CDATA[CAMBRIDGE, Mass. and TOKYO, Aug.  07, 2020  (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer\u2019s disease. The application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date on March 7, 2021, and the FDA has stated that, if possible, it plans to act early on this application under an expedited review. If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer\u2019s disease and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes.]]><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":74553,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[71350,71361],"tags":[],"_links":{"self":[{"href":"https:\/\/www.pm360online.com\/wp-json\/wp\/v2\/posts\/708195"}],"collection":[{"href":"https:\/\/www.pm360online.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pm360online.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pm360online.com\/wp-json\/wp\/v2\/users\/74553"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pm360online.com\/wp-json\/wp\/v2\/comments?post=708195"}],"version-history":[{"count":0,"href":"https:\/\/www.pm360online.com\/wp-json\/wp\/v2\/posts\/708195\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.pm360online.com\/wp-json\/wp\/v2\/media?parent=708195"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pm360online.com\/wp-json\/wp\/v2\/categories?post=708195"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pm360online.com\/wp-json\/wp\/v2\/tags?post=708195"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}