{"id":27415,"date":"2014-10-01T12:17:53","date_gmt":"2014-10-01T12:17:53","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=27415"},"modified":"2014-10-06T11:12:30","modified_gmt":"2014-10-06T11:12:30","slug":"eu-gives-positive-opinion-for-coformulated-darunavircobicistat","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/27415","title":{"rendered":"Positive opinion to approve of darunavir\/cobicistat in Europe"},"content":{"rendered":"<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong>On 25 September 2014, the Committee for Medicinal Products for Human Use (CHMP) recommended granting market authorisation for a coformulated version of darunavir (800 mg) plus the pharmacokinetic booster cobicistat (150 mg).<\/strong> [1]<\/p>\n<p>The indication is for use in treatment-naive and treatment-experienced adults with no darunavir-associated mutations.<\/p>\n<p>This formulation be the first single-pill, once-daily, boosted protease inhibitor for rich countries (as there is a generic atazanavir\/ritonavir).<\/p>\n<p>The same meeting also extended the indication for darunavir to include boosting with either ritonavir or cobicistat. [1]<\/p>\n<p>Recommendations from the CHMP are usually followed with full approval, expected within three months.<\/p>\n<p>The formulation is manufactured by Janssen-Cilag and will be marketed in Europe with the brand name Rezolsta. It is already available in Canada under the trade name Prezcobix. [2]<\/p>\n<p>References:<\/p>\n<ol>\n<li>European Union CHMP. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 September 2014. (26 September 2014).<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2014\/09\/news_detail_002170.jsp&amp;mid=WC0b01ac058004d5c1\">http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2014\/09\/news_detail_002170.jsp&amp;mid=WC0b01ac058004d5c1<\/a><\/li>\n<li>PR Newswire. Prezcobix now available for Canadians living with HIV. (17 September 2014).<br \/>\n<a href=\"http:\/\/www.prnewswire.com\/news-releases\/prezcobix-now-available-for-canadians-living-with-hiv-275413881.html\">http:\/\/www.prnewswire.com\/news-releases\/prezcobix-now-available-for-canadians-living-with-hiv-275413881.html<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 25 September 2014, the Committee for Medicinal Products for Human Use (CHMP) recommended granting market authorisation for a coformulated version of darunavir (800 mg) plus the pharmacokinetic booster cobicistat (150 mg). [1] The indication is &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-27415","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/27415","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=27415"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/27415\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=27415"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=27415"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=27415"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}