{"id":5727,"date":"2006-02-09T17:07:51","date_gmt":"2006-02-09T16:07:51","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=5727"},"modified":"2013-12-07T08:36:19","modified_gmt":"2013-12-07T08:36:19","slug":"tmc114-darunavir-new-drug-applications-submitted-to-us-and-european-regulatory-agencies","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/5727","title":{"rendered":"TMC114 (darunavir) new drug applications submitted to US and European regulatory agencies"},"content":{"rendered":"<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong>On 27 December, Tibotec Pharmaceuticals announced the submission of a New Drug Application to the United States Food and Drug Administration (FDA) for TMC114, an investigational protease inhibitor, being studied as a potential for treatment for people infected with HIV-1. A similar application to the European Agency for the Evaluation of Medicinal Products (EMEA) was submitted on 11 January 2006.<\/strong><\/p>\n<p>The submissions are based on the efficacy and safety results of the 24 week dose-finding phase of two Phase IIb randomised, controlled studies, POWER 1 and POWER 2, and supportive open label safety data from the POWER 3 analyses. The POWER 1 data were presented at the International AIDS Society (IAS) conference in Rio de Janeiro in July 2005. The POWER 2 data were presented earlier this month at the 45th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington D.C.<\/p>\n<p>TMC114, boosted with low-dose ritonavir, is currently in Phase III clinical trials in both treatment-experienced and treatment-naive HIV-1 infected patients. TMC114 is available through an expanded access program (EAP) in the United States for people living with HIV who need the compound to construct a viable treatment regimen and who are not eligible for Tibotec clinical trials.<\/p>\n<p>For further information, please visit:<\/p>\n<p><a href=\"http:\/\/www.tibotec.com\">http:\/\/www.tibotec.com<\/a><\/p>\n<p>Source: Tibotec Pharmaceuticals Ltd.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 27 December, Tibotec Pharmaceuticals announced the submission of a New Drug Application to the United States Food and Drug Administration (FDA) for TMC114, an investigational protease inhibitor, being studied as a potential for treatment for &hellip;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-5727","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/5727","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=5727"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/5727\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=5727"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=5727"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=5727"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}