{"id":36951,"date":"2019-12-13T08:31:18","date_gmt":"2019-12-13T08:31:18","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=36951"},"modified":"2021-01-23T19:26:25","modified_gmt":"2021-01-23T19:26:25","slug":"fostemsavir-submitted-to-us-fda-for-multidrug-resistant-hiv","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/36951","title":{"rendered":"Fostemsavir submitted to US FDA for multidrug resistant HIV"},"content":{"rendered":"

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

On 5 December 2019, ViiV Healthcare announced that the company had submitted\u00a0a new drug application for fostemsavir to the US FDA. [1]<\/span><\/strong><\/p>\n

Fostemsavir is a gp120 attachment inhibitor, the first drug in this new class, that was developed as a treatment for people with multi-drug resistance to other HIV drugs.<\/span><\/p>\n

The submission is based on 96-week results from the phase 3 BRIGHTE study. [2, 3]<\/span><\/p>\n

Submission to the EMA for access in the EU is expected in early 2020.<\/span><\/p>\n

comment<\/span><\/h3>\n

A limited named patient access programme is available, including in the UK, for people who are urgently need access to fostemsavir before it will be approved.<\/span><\/strong><\/p>\n

For details, doctors should directly contact ViiV Healthcare.<\/span><\/strong><\/p>\n

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

    \n
  1. ViiV Healthcare press release. <\/span>ViiV Healthcare submits New Drug Application to the FDA for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available. (5 December 2019).
    \nhttps:\/\/www.gsk.com\/en-gb\/media\/press-releases\/viiv-healthcare-submits-new-drug-application-to-the-fda-for-fostemsavir-an-investigational-first-in-class-attachment-inhibitor-for-the-treatment-of-hiv-in-adults<\/span><\/a><\/li>\n
  2. Collins S. Fostemsavir: 96-week follow-up in people with multi-drug resistance. HTB 24 July 2019.
    \n<\/span>    https:\/\/i-base.info\/htb\/36390<\/span><\/a><\/li>\n
  3. Lataillade M et al Week 96 safety and efficacy of the novel HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced participants infected with multi-drug resistant HIV-1 (BRIGHTE study). 10th IAS Conference on HIV Science (IAS 2019), 21-24 July 2019, Mexico City. Oral abstract MOAB0102.
    \n    http:\/\/programme.ias2019.org\/Abstract\/Abstract\/3372<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 5 December 2019, ViiV Healthcare announced that the company had submitted\u00a0a new drug application for fostemsavir to the US FDA. [1] Fostemsavir is a gp120 attachment inhibitor, the first drug in this new class, that …<\/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-36951","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/36951","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=36951"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/36951\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=36951"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=36951"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=36951"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}