{"id":37092,"date":"2020-01-29T08:40:35","date_gmt":"2020-01-29T08:40:35","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=37092"},"modified":"2020-01-29T12:36:42","modified_gmt":"2020-01-29T12:36:42","slug":"fostemsavir-submitted-to-ema-for-treating-multidrug-resistant-hiv","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/37092","title":{"rendered":"Fostemsavir submitted to EMA for treating multidrug resistant HIV"},"content":{"rendered":"

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

On 10 January 2020, ViiV Healthcare submitted a regulatory application for fostemsavir to the European Medicines Agency (EMA). [1]<\/span><\/b><\/p>\n

The application seeks approval of fostemsavir, used in combination with other antiretrovirals, for the treatment of adults with multidrug resistant HIV who are otherwise unable to construct a suppressive antiviral regimen due to resistance, intolerance or safety considerations.<\/span><\/p>\n

The EMA\u2019s Committee for Medicinal Products for Human Use (CHMP) has granted an accelerated assessment for fostemsavir. This reduces the timeframe for review based on meeting a currently unmet medical need.<\/span><\/p>\n

Submission is based on the\u00a0<\/span>96-week results from the phase 3 BRIGHTE study presented at the 10th IAS Conference on HIV Science (IAS 2019) in Mexico City. [2]<\/span><\/p>\n

A similar application to the US FDA was submitted in December 2019, also with accelerated approval status. [3] <\/span><\/p>\n

References<\/span><\/p>\n

    \n
  1. ViiV Healthcare press statement. ViiV Healthcare submits regulatory application to the European Medicines Agency for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available. (10 January 2020).
    \n<\/span>https:\/\/viivhealthcare.com\/en-gb\/media\/press-releases\/2020\/january\/viiv-healthcare-submits-regulatory-application-to-the-european-m<\/span><\/a><\/li>\n
  2. Fostemsavir: 96-week follow-up in people with multi-drug resistance. HTB, 24 July 2019.
    \n    https:\/\/i-base.info\/htb\/36390<\/a><\/li>\n
  3. Fostemsavir submitted to US FDA for multidrug resistant HIV. HTB December 2019.
    \n<\/span>    https:\/\/i-base.info\/htb\/36951<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 10 January 2020, ViiV Healthcare submitted a regulatory application for fostemsavir to the European Medicines Agency (EMA). [1] The application seeks approval of fostemsavir, used in combination with other antiretrovirals, for the treatment of adults …<\/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-37092","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/37092","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=37092"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/37092\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=37092"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=37092"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=37092"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}