{"id":25835,"date":"2014-05-27T12:05:03","date_gmt":"2014-05-27T12:05:03","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=25835"},"modified":"2014-05-28T08:06:14","modified_gmt":"2014-05-28T08:06:14","slug":"ema-fast-track-sofosbuvirledipasvir-fdc-for-hepatitis-c","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/25835","title":{"rendered":"EMA fast-track sofosbuvir\/ledipasvir FDC for hepatitis C"},"content":{"rendered":"<p><strong>Gilead press statement<\/strong><\/p>\n<p><strong>On 27 March 2014, Gilead announced that the European Medicines Agency (EMA) has agreed to an accelerated assessment for a once-daily fixed-dose combination of sofosbuvir plus ledipasvir.<\/strong><\/p>\n<p>Sofosbuvir is a nucleotide analogue polymerase inhibitor and ledipasvir is an NS5A inhibitor, that together are indicated as a treatment of chronic hepatitis C genotype 1.<\/p>\n<p>The data included in the application, which was submitted on February 27, 2014, supports the use of LDV\/SOF among adult patients with genotype 1 HCV infection for eight or 12 weeks, (depending on their prior treatment history and whether they have cirrhosis).<\/p>\n<p>The Marketing Authorisation Application (MAA) is supported by three Phase 3 studies, ION-1, ION-2 and ION-3, in which nearly 2,000 patients were randomised to receive the fixed-dose combination, with or without ribavirin, for treatment durations of 8, 12 or 24 weeks.<\/p>\n<p>Accelerated assessment reduces the review period by approximately two months.<\/p>\n<p>Source:<\/p>\n<p>Gilead press statement. European Medicine&#8217;s Agency validates Gilead&#8217;s marketing application for ledfipasvir\/sofosbuvir fixed-dose combinationtablet for genotype 1 chronic hepatitis C infection. (27 March 2014).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Gilead press statement On 27 March 2014, Gilead announced that the European Medicines Agency (EMA) has agreed to an accelerated assessment for a once-daily fixed-dose combination of sofosbuvir plus ledipasvir. Sofosbuvir is a nucleotide analogue polymerase inhibitor and ledipasvir is &hellip;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[24],"tags":[],"class_list":["post-25835","post","type-post","status-publish","format-standard","hentry","category-hepatitis-coinfection"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/25835","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=25835"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/25835\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=25835"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=25835"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=25835"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}