{"id":50208,"date":"2025-02-04T09:20:14","date_gmt":"2025-02-04T09:20:14","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=50208"},"modified":"2025-02-18T19:46:17","modified_gmt":"2025-02-18T19:46:17","slug":"50208","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/50208","title":{"rendered":"Lenacapavir for PrEP submitted to EMA for EU and global use"},"content":{"rendered":"

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

On 3 February 2025, the capsid inhibitor lenacapavir was submitted to the European<\/strong>\u00a0Medicines Agency for use as PrEP. [1]<\/strong><\/p>\n

Two applications were submitted \u2014 one to cover use in the EU, and an EU-Medicines for All (EU-M4all) application for global use in low- and middle-income countries.<\/b><\/p>\n

Lenacapavir is a long-acting capsid inhibitor given by subcutaneous injection every six months, with an oral boosting dose also given for the first two days.<\/p>\n

The PrEP applications are based on the results from the PURPOSE 1 and 2 studies. These large international phase 3 studies reported 100% and 96% efficacy at the IAS and HIV R4P conferences last year. Because only two people became HIV positive in PURPOSE 2 these results are also being reported as lenacapavir protecting 99.9% of participants. These two cases have not yet been explained.<\/p>\n

Details of submission to the UK’s MHRA have not yet been announced.<\/p>\n

Lenacapavir is being developed and marketed by Gilead Sciences.<\/p>\n

comment<\/h3>\n

Only needing a subcutaneous injection twice a year means that lenacapavir could play a unique role in dramatically preventing HIV transmission globally. This depends on very broad access (similar to a vaccine programme) which in turn depends on an affordable price.<\/span><\/strong><\/p>\n

Lenacapavir is already approved as HIV treatment for people with extensive multidrug resistance (MDR) and it has also produced incredibly high efficacy as PrEP. [2]<\/strong><\/p>\n

Lenacapavir PrEP was submitted to the US FDA in December 2024. [3]<\/strong><\/p>\n

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

    \n
  1. Gilead press release. Gilead submits marketing authorisation applications to European Medicines Agency for twice-yearly lenacapavir for HIV prevention. (3 February 2025).
    \nhttps:\/\/www.gilead.com\/company\/company-statements\/2025\/gilead-submits-marketing-authorization-applications-to-european-medicines-agency-for-twice-yearly-lenacapavir-for-hiv-prevention<\/a><\/li>\n
  2. Lenacapavir submitted to the US FDA with an indication for HIV PrEP. HTB (1 January 2024).
    \n<\/span>    https:\/\/i-base.info\/htb\/49765<\/a><\/li>\n
  3. Lenacapavir approved in the EU and UK to treat multidrug resistant HIV. HTB (1 September 2022).
    \n<\/span>    https:\/\/i-base.info\/htb\/43776<\/a><\/li>\n<\/ol>\n\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 3 February 2025, the capsid inhibitor lenacapavir was submitted to the European\u00a0Medicines Agency for use as PrEP. [1] Two applications were submitted \u2014 one to cover use in the EU, and an EU-Medicines for All …<\/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-50208","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\/50208","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=50208"}],"version-history":[{"count":11,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/50208\/revisions"}],"predecessor-version":[{"id":50219,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/50208\/revisions\/50219"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=50208"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=50208"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=50208"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}