Lenacapavir for PrEP submitted to EMA for EU and global use
4 February 2025. Related: Early access, Antiretrovirals, HIV prevention and transmission.
Simon Collins, HIV i-Base
On 3 February 2025, the capsid inhibitor lenacapavir was submitted to the European Medicines Agency for use as PrEP. [1]
Two applications were submitted — 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.
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.
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.
Details of submission to the UK’s MHRA have not yet been announced.
Lenacapavir is being developed and marketed by Gilead Sciences.
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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.
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]
Lenacapavir PrEP was submitted to the US FDA in December 2024. [3]
References
- Gilead press release. Gilead submits marketing authorisation applications to European Medicines Agency for twice-yearly lenacapavir for HIV prevention. (3 February 2025).
https://www.gilead.com/company/company-statements/2025/gilead-submits-marketing-authorization-applications-to-european-medicines-agency-for-twice-yearly-lenacapavir-for-hiv-prevention - Lenacapavir submitted to the US FDA with an indication for HIV PrEP. HTB (1 January 2024).
https://i-base.info/htb/49765 - Lenacapavir approved in the EU and UK to treat multidrug resistant HIV. HTB (1 September 2022).
https://i-base.info/htb/43776