{"id":45829,"date":"2023-08-01T07:25:10","date_gmt":"2023-08-01T07:25:10","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=45829"},"modified":"2023-08-03T10:51:27","modified_gmt":"2023-08-03T10:51:27","slug":"cab-la-receives-positive-opinion-for-eu-approval-as-prep","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/45829","title":{"rendered":"CAB-LA receives positive opinion for EU approval as PrEP"},"content":{"rendered":"

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

On 24 July 2023, the European Medicine Agency (EMA) issued a positive opinion on approving long-acting cabotegravir injections (CAB-LA) and related oral tablets for HIV PreExposure Prophylaxis (PrEP). [1]<\/strong><\/p>\n

This is based on results from two large phase 3 international studies: HPTN 083 and 084 studies.<\/p>\n

The indication will be to reduce the risk of sexually acquired HIV in adults and adolescents at high risk of infection, weighing at least 35 kg.<\/p>\n

The US FDA approved CAB-LA PrEP in December 2021. As we noted then, price will determine the degree to which injectable PrEP will be accessed in Europe. [2]<\/p>\n

In the UK, NICE are currently leading a scoping consultation for CAB-LA for PrEP, although it has not yet been approved by the MHRA. [3]<\/p>\n

Source<\/p>\n

    \n
  1. ViiV press statement. ViiV Healthcare\u2019s cabotegravir for HIV prevention receives positive CHMP opinion from European Medicines Agency. (24 July 2023).
    \nhttps:\/\/www.gsk.com\/en-gb\/media\/press-releases\/viiv-healthcare-s-cabotegravir-for-hiv-prevention-receives-positive-chmp-opinion-from-european-medicines-agency\/<\/a><\/li>\n
  2. US FDA approves long-acting cabotegravir injections for PrEP: price set at $22,000 a year. HTB December 2021.
    \n    https:\/\/i-base.info\/htb\/41890<\/a><\/li>\n
  3. Cabotegravir injections for preventing HIV-1 in adults and young people ID6255.
    \n    https:\/\/www.nice.org.uk\/guidance\/indevelopment\/gid-ta11304<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 24 July 2023, the European Medicine Agency (EMA) issued a positive opinion on approving long-acting cabotegravir injections (CAB-LA) and related oral tablets for HIV PreExposure Prophylaxis (PrEP). [1] This is based on results from two …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,10],"tags":[],"class_list":["post-45829","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals","category-transmission-and-prevention"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/45829","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=45829"}],"version-history":[{"count":11,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/45829\/revisions"}],"predecessor-version":[{"id":45902,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/45829\/revisions\/45902"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=45829"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=45829"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=45829"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}