{"id":32981,"date":"2017-11-24T14:44:02","date_gmt":"2017-11-24T14:44:02","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=32981"},"modified":"2018-07-01T17:42:02","modified_gmt":"2018-07-01T17:42:02","slug":"darunavir-based-single-pill-fdc-approved-in-eu","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/32981","title":{"rendered":"Darunavir-based single pill FDC approved in EU (Symtuza)"},"content":{"rendered":"<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong>On 27 September 2017, the first protease inhibitor-based fixed dose combination (FDC) was approved in Europe by the European Medicines Agency (EMA).<\/strong> [1]<\/p>\n<p>The once-daily FDC combines darunavir 800 mg, cobicistat 150 mg and emtricitabine\/tenofovir alafenamide 200 mg\/10 mg fixed-dose combination (D\/C\/F\/TAF).<\/p>\n<p>The indication is for HIV positive adults and adolescents aged 12 years and older.<\/p>\n<p>The combination needs to be taken once-daily with food. Approval is based on phase 3 studies showing bioequivalence to the individual components being taken separately.<\/p>\n<p>This FDC is marketed by Janssen-Cilag with the brand name Symtuza.<\/p>\n<p>For full details see the SPC and patient information on the EMA website. [2]<\/p>\n<p>References:<\/p>\n<ol>\n<li>Janssen press statement. European Commission approves Symtuza for the treatment of HIV-1 in adults and adolescents in Europe. (27 September 2017).<br \/>\n<a href=\"http:\/\/www.investor.jnj.com\/releases.cfm\">http:\/\/www.investor.jnj.com\/releases.cfm<\/a><\/li>\n<li>European Summary of Product Charateristics (SPC) for Symtuza. (September 2017).<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/medicines\/human\/medicines\/004391\/human_med_002165.jsp&amp;mid=WC0b01ac058001d124\">http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/medicines\/human\/medicines\/004391\/human_med_002165.jsp&amp;mid=WC0b01ac058001d124<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 27 September 2017, the first protease inhibitor-based fixed dose combination (FDC) was approved in Europe by the European Medicines Agency (EMA). [1] The once-daily FDC combines darunavir 800 mg, cobicistat 150 mg and emtricitabine\/tenofovir alafenamide &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-32981","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/32981","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=32981"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/32981\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=32981"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=32981"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=32981"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}