{"id":36035,"date":"2019-04-30T08:35:47","date_gmt":"2019-04-30T08:35:47","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=36035"},"modified":"2019-04-30T18:29:35","modified_gmt":"2019-04-30T18:29:35","slug":"dual-long-acting-cabotegravir-rilpivirine-injection-submitted-to-fda","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/36035","title":{"rendered":"Dual long-acting cabotegravir\/rilpivirine injection submitted to FDA"},"content":{"rendered":"<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong>On 29 April 2019, ViiV Healthcare announced that the long-acting two-drug injection formulation of cabotegravir\/rilpivirine has been submitted to the US FDA. [1]<\/strong><\/p>\n<p>This announcement was expected following the presentation at CROI 2019 last month of the primary endpoint results from the phase 3 FLAIR and ATLAS studies. [2]<\/p>\n<p>These studies reported &gt;90% viral suppression &lt;50 copies\/mL at week-48 meeting criteria for non-inferiority compared to three-drug oral therapy.<\/p>\n<p>The press release also notes that submission to the European Medicines Agency (EMA) is expected within the next few months.<\/p>\n<p>References<\/p>\n<ol>\n<li>ViiV press statement. ViiV Healthcare submits New Drug Application to US FDA for the first monthly, injectable, two-drug regimen of cabotegravir and rilpivirine. (29 April 2019).<br \/>\n<a href=\"https:\/\/www.viivhealthcare.com\/en-gb\/media\/press-releases\/2019\/april\/viiv-healthcare-submits-new-drug-application-to-us-fda-for-the-first-monthly-injectable-two-drug-regimen-of-cabotegravir-and-rilpivirine-for-treatment-of-hiv\/\" rel=\"noopener\">https:\/\/www.viivhealthcare.com\/en-gb\/media<\/a>\u00a0 (direct link)<\/li>\n<li>Collins S. Phase 3 results with dual therapy cabotegravir\/rilpivirine long-acting injections: ATLAS and FLAIR studies. HTB: 20(4), 12 March 2019.<br \/>\n<a href=\"https:\/\/i-base.info\/htb\/35812\">https:\/\/i-base.info\/htb\/35812<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 29 April 2019, ViiV Healthcare announced that the long-acting two-drug injection formulation of cabotegravir\/rilpivirine has been submitted to the US FDA. [1] This announcement was expected following the presentation at CROI 2019 last month of &hellip;<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-36035","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/36035","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\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=36035"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/36035\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=36035"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=36035"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=36035"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}