{"id":800,"date":"2010-09-03T11:08:39","date_gmt":"2010-09-03T15:08:39","guid":{"rendered":"http:\/\/sciencebusiness.technewslit.com\/?p=800"},"modified":"2010-09-03T11:10:18","modified_gmt":"2010-09-03T15:10:18","slug":"european-approval-sought-for-daily-hiv-treatment","status":"publish","type":"post","link":"https:\/\/technewslit.com\/sciencebusiness\/?p=800","title":{"rendered":"European Approval Sought for Daily HIV Treatment"},"content":{"rendered":"<p>Gilead Sciences Inc. of Foster City, California is <a href=\"http:\/\/www.gilead.com\/pr_1466665\">seeking approval to market<\/a> a combination of its Truvada drug with Tibotec Pharmaceuticals&#8217; TMC278 as a single-dose daily treatment for HIV infection. If approved, the new single-tablet regimen would be only the second product that contains a complete antiretroviral treatment regimen in a single once-daily tablet, according to the company.<\/p>\n<p>Truvada is a combination of <a href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmedhealth\/PMH0000248\">emtricitabine<\/a>, a nucleoside reverse transcriptase inhibitor that slows the spread of HIV and <a href=\"http:\/\/www.rxlist.com\/viread-drug.htm\">tenofovir disoproxil<\/a> that decreases the amount of HIV in the body. <a href=\"http:\/\/www.aidsmeds.com\/archive\/TMC-278_1619.shtml\">TMC278<\/a> made by <a href=\"http:\/\/www.tibotec.com\/\">Tibotec Pharmaceuticals<\/a> is a non-nucleoside reverse transcriptase inhibitor that prevents HIV from entering the nucleus of healthy T-cells.<\/p>\n<p>The Marketing Authorization Application to the European Medicines Agency (EMA) will be reviewed by EMA&#8217;s Committee for Medicinal Products for Human Use under the centralized licensing procedure, which, if approved, provides one marketing authorization in all 27 member states of the European Union. A similar application for TMC278 also is being submitted by Tibotec to the EMA for review.<\/p>\n<p>Gilead says this application comes after a 48-week data collection from two phase 3 double-blind, randomized studies. One study\u00a0 evaluated the safety and efficacy of TMC278 in treatment-naive HIV-1 infected adults. A second bioequivalence study conducted by Gilead demonstrated that the formulation of the fixed-dose combination of Truvada and TMC278 achieved the same levels of medication in the blood as the component products dosed simultaneously.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Gilead Sciences Inc. of Foster City, California is seeking approval to market a combination of its Truvada drug with Tibotec Pharmaceuticals&#8217; TMC278 as a single-dose daily treatment for HIV infection. If approved, the new single-tablet regimen would be only the second product that contains a complete antiretroviral treatment regimen in a single once-daily tablet, according [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[45,54,27],"class_list":["post-800","post","type-post","status-publish","format-standard","hentry","category-regulations","tag-europe","tag-hiv","tag-pharmaceuticals"],"_links":{"self":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts\/800","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=800"}],"version-history":[{"count":4,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts\/800\/revisions"}],"predecessor-version":[{"id":804,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts\/800\/revisions\/804"}],"wp:attachment":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=800"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=800"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=800"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}