{"id":29523,"date":"2016-02-01T12:11:07","date_gmt":"2016-02-01T12:11:07","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=29523"},"modified":"2016-02-05T11:39:11","modified_gmt":"2016-02-05T11:39:11","slug":"european-application-underway-for-prep-indication-for-tenofovirftc","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/29523","title":{"rendered":"European application underway for PrEP indication for tenofovir\/FTC"},"content":{"rendered":"
\"PrEP

PrEP smurf “PrEP now!”<\/p><\/div>\n

Simon Collins, HIV i-Base<\/strong><\/p>\n

On 1 February 2016, Gilead Sciences issued a press release about its application for an extended license in the European Union for tenofovir\/FTC to be prescribed as pre-exposure prophylaxis (PrEP).<\/strong><\/p>\n

The application has been reviewed and accepted by the European Medicines Agency (EMA) and is now under evaluation.<\/p>\n

Until now, it was unclear whether or not Gilead had submitted a dossier for PrEP and indeed whether the EMA had resolved their criteria – and priorities – in order to make such an evaluation.<\/p>\n

\"PrEP-300x152

Cilead’s tenofovir\/FTC formulation<\/p><\/div>\n

Both Gilead and the EMA have been widely criticised, including by community groups, for the slow timeline compared to the US, where the FDA first approved PrEP in July 2012.<\/p>\n

The role of the EMA was particularly helpful, overstepping its role to evaluating drug safety and efficacy by suggesting PrEP was a low priority due to concerns over potential behaviour changes that have not been reported in randomised studies.<\/p>\n

While the lack of an indication should not be a barrier to current prescribing – ART is widely used as PEP for example without an indication – approval is an essential step to enable broad commissioning and widespread access in many countries.<\/p>\n

Tenofovir\/FTC was also approved for PrEP in Kenya and South Africa in 2015, with regulatory submissions pending in Australia, Brazil, Canada, Peru and Thailand and access in France following a Temporary Recommendation for Use by the French regulatory agency.<\/p>\n

Comment<\/h3>\n

If this application is given an accelerated review, a decision might be given with 90-120 days.<\/strong><\/p>\n

The timeline for the EMA decision however has not yet been reported.<\/strong><\/p>\n

Reference:<\/p>\n

Gilead press statement. European Medicines Agency validates Gilead’s type II variation application for Truvada for reducing the risk of sexually acquired HIV. (01 February 2016).
\nhttp:\/\/www.gilead.com\/news\/press-releases\/2016\/2\/european-medicines-agency-validates-gileads-type-ii-variation-application-for-truvada-for-reducing-the-risk-of-sexually-acquired-hiv<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Simon Collins, HIV i-Base On 1 February 2016, Gilead Sciences issued a press release about its application for an extended license in the European Union for tenofovir\/FTC to be prescribed as pre-exposure prophylaxis (PrEP). The application has been reviewed and …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[],"class_list":["post-29523","post","type-post","status-publish","format-standard","hentry","category-transmission-and-prevention"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/29523","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=29523"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/29523\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=29523"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=29523"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=29523"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}