Positive opinion for lenacapavir indication as PrEP in the EU
25 July 2025. Related: Early access, Antiretrovirals, HIV prevention and transmission.
Simon Collins, HIV i-Base
On 25 July 2025, the European Medicines Agency (EMA) issued a press release about the positive indication for lenacapavir to be approved as PrEP in the EU. [1]
Approval based on such recommendations usually follow within the 1 to 3 months.
In consideration of the new indication, the patent will be extended by a further year.
Lenacapavir was highly effective and safe in two large randomised international studies (PURPOSE 1 and PURPOSE 2), both previously reported in HTB.
Post-approval access though will be closely related to the price charged, which us currently listed as US$ 28,000 a year (2 x 6-monthly injections). This is likely to need a significant discount for this to be prescribed in Europe. [2]
Lenacapavir was developed by Gilead Sciences and is marketed for PrEP as Yeztugo in the US. The brand name for PrEP in the EU will be Yeytuo.
The brand name for the indication to treat MDR HIV is Sunlenca.
References
- EMA. New injection for easier prevention of HIV infection in the EU and worldwide. (25 July 2025).
https://www.ema.europa.eu/en/news/new-injection-easier-prevention-hiv-infection-eu-worldwide - Long-acting injectable PrEP approved in the US: priced at $28,000 a year. HTB (1 July 2025).
https://i-base.info/htb/51357