{"id":32378,"date":"2017-08-10T12:04:07","date_gmt":"2017-08-10T12:04:07","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=32378"},"modified":"2017-08-14T13:24:18","modified_gmt":"2017-08-14T13:24:18","slug":"fda-grant-priority-review-for-ibalizumab","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/32378","title":{"rendered":"FDA grant priority review for ibalizumab"},"content":{"rendered":"<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong>On 30 June 2017, Theratechnologies issued a press release about the US FDA decision to accept a priority review for ibalizumab, a monoclonal antibody currently in phase 3 studies as a treatment for multidrug resistant HIV.<\/strong><\/p>\n<p>The FDA also set a timeline of January 2018 to receive the application. Priority review reduces the time taken to review the application, once submitted, from approximately 10 months to 6 months.<\/p>\n<p>The review was based on phase 3 results from the single arm, 24-week TMB-301 study that used ibalizumab in addition to optimised background ART in people with drug resistance to at drugs from at least three classes.<\/p>\n<p>Ibalizumab is an HIV entry inhibitor that is given by infusion every two weeks. It was also designated a breakthrough therapy by the FDA in 2015 and was granted Orphan Drug designation in 2014.<\/p>\n<p>Ibalizumab is being developed by TaiMed Biologics, but with be marketed and distributed by Theratechnologies in the US<\/p>\n<p>Reference:<\/p>\n<p>FDA grants priority review to HIV monoclonal antibody and long-acting investigational antiretroviral ibalizumab. (30 June 2017)<br \/>\n<a href=\"http:\/\/theratech.com\/sites\/default\/files\/news_release_en\/nr-20170630-en.pdf\">http:\/\/theratech.com\/sites\/default\/files\/news_release_en\/nr-20170630-en.pdf<\/a>\u00a0(PDF)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 30 June 2017, Theratechnologies issued a press release about the US FDA decision to accept a priority review for ibalizumab, a monoclonal antibody currently in phase 3 studies as a treatment for multidrug resistant HIV. &hellip;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-32378","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/32378","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=32378"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/32378\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=32378"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=32378"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=32378"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}