{"id":49765,"date":"2025-01-01T12:00:23","date_gmt":"2025-01-01T12:00:23","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=49765"},"modified":"2025-01-15T21:07:17","modified_gmt":"2025-01-15T21:07:17","slug":"lenacapavir-submitted-to-the-us-fda-for-hiv-prep","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/49765","title":{"rendered":"Lenacapavir submitted to the US FDA with an indication for HIV PrEP"},"content":{"rendered":"<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong>On 19 December 2024, Gilead announced that it had submitted a new drug application to the US FDA for lenacapavir to be used as 6-monthly HIV PrEP. [1]<\/strong><\/p>\n<p>The submission is primarily based on the results from the two large randomised PURPOSE 1 and 2 phase 3 studies, that were recently reported in July and October at the IAS and R4P conferences respectively.<\/p>\n<p>Both studies showed lenacapavir to be highly effective at preventing new HIV infections with 100% and 96% efficacy compared to control arms, with higher adherence driving superiority results compared to oral TDF\/FTC.<\/p>\n<p>The application has been granted\u00a0Breakthrough Therapy Designation for a faster review. This also included rolling submission of new data as it becomes available, with the first results submitted at the end of November.<\/p>\n<h3>comment<\/h3>\n<p><strong>Although the press release didn\u2019t include a timeline, the breakthrough designation should enable a decision within six months. WHO generally depends on US approval before a drug can be included in the list of essential medicines.<\/strong><\/p>\n<p><strong>A decision on the price in high-income countries is only usually announced after FDA approval.<\/strong><\/p>\n<p><strong>The focus on approval in low- and middle-income settings will depend on international funders committing to ambitious programmes that will enable economies of scale.<\/strong><\/p>\n<p>Reference<\/p>\n<ol>\n<li>Gilead press release. Gilead Submits New Drug Application to U.S. Food and Drug Administration for Twice-Yearly Lenacapavir for HIV Prevention. (19 December 2024).<br \/>\n<a href=\"https:\/\/www.gilead.com\/company\/company-statements\/2024\/gilead-submits-new-drug-application-to-us-food-and-drug-administration-for-twice-yearly-lenacapavir-for-hiv-prevention\">www.gilead.com\/company\/company-statements\/2024\/gilead-submits-new-drug-application-to-us-food-and-drug-administration-for-twice-yearly-lenacapavir-for-hiv-prevention<\/a><\/li>\n<\/ol>\n<div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 19 December 2024, Gilead announced that it had submitted a new drug application to the US FDA for lenacapavir to be used as 6-monthly HIV PrEP. [1] The submission is primarily based on the results &hellip;<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,38,10],"tags":[],"class_list":["post-49765","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals","category-treatment-access","category-transmission-and-prevention"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/49765","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=49765"}],"version-history":[{"count":4,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/49765\/revisions"}],"predecessor-version":[{"id":50060,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/49765\/revisions\/50060"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=49765"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=49765"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=49765"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}