{"id":41294,"date":"2021-09-17T07:42:49","date_gmt":"2021-09-17T07:42:49","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=41294"},"modified":"2021-09-19T21:42:47","modified_gmt":"2021-09-19T21:42:47","slug":"lenacapavir-submitted-to-ema-for-mdr-hiv","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/41294","title":{"rendered":"Lenacapavir submitted to EMA for MDR HIV"},"content":{"rendered":"<div>\n<p class=\"HTBsubhead2articletitle\"><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<\/div>\n<div>\n<p class=\"HTBBODYtext\"><strong><span lang=\"EN-US\">On 19 August 2021, Gilead submitted data on lenacapavir to the EMA for a limited indication of treatment for HIV with multidrug resistance (MDR). [1]<\/span><\/strong><\/p>\n<\/div>\n<div>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">The application is based on 26-week data from the phase 2\/3 CAPELLA study.<\/span><\/p>\n<\/div>\n<div>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">Lenacapavir us given as a sub-cutaneous long-acting injection every six months.<\/span><\/p>\n<\/div>\n<div>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">The submission to the US FDA was in June 2021.<\/span><\/p>\n<\/div>\n<div>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">\u00a0<\/span>References<\/p>\n<\/div>\n<div>\n<ol>\n<li class=\"HTBreferences\"><span lang=\"EN-US\">Gilead press statement. European Medicines Agency validates Gilead\u2019s marketing authorization application for lenacapavir, an investigational, long-acting capsid Inhibitor for the treatment of HIV-1 in people with limited therapy options. (19 August 2021).<br \/>\n<\/span><a href=\"https:\/\/www.gilead.com\/news-and-press\/press-room\/press-releases\/2021\/8\/european-medicines-agency-validates-gileads-marketing-authorization-application-for-lenacapavir-an-investigational-longacting-capsid-inhibitor-for\">https:\/\/www.gilead.com\/news-and-press\/press-room\/press-releases\/2021\/8\/european-medicines-agency-validates-gileads-marketing-authorization-application-for-lenacapavir-an-investigational-longacting-capsid-inhibitor-for<\/a><\/li>\n<li class=\"HTBreferences\">IAS 2021: lenacapavir studies show impressive results in naive, extensive drug resistance and potential as PrEP. HTB (August 2021).<br \/>\n<a href=\"https:\/\/i-base.info\/htb\/41003\">https:\/\/i-base.info\/htb\/41003<\/a><\/li>\n<\/ol>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 19 August 2021, Gilead submitted data on lenacapavir to the EMA for a limited indication of treatment for HIV with multidrug resistance (MDR). [1] The application is based on 26-week data from the phase 2\/3 &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-41294","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/41294","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=41294"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/41294\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=41294"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=41294"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=41294"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}