European Commission Authorizes Twice-Yearly Yeytuo® (Lenacapavir) for HIV Prevention

Gilead Sciences, Inc. announced that, on 25 August 2025, the European Commission (EC) has granted marketing authorization for Yeytuo® (lenacapavir)—the company’s twice-yearly injectable HIV-1 capsid inhibitor—for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk who weigh at least 35kg. Yeytuo is the first and only twice-yearly PrEP option to be approved for use in the European Union’s 27 member states, as well as Norway, Iceland and Liechtenstein.

The marketing authorization application (MAA) was reviewed under an accelerated timeline based on the assessment by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) that twice-yearly Yeytuo is a product of major interest for public health. In July, the CHMP adopted a positive opinion recommending Yeytuo for EC authorization. Additionally, lenacapavir will be granted one additional year of market protection in the EU as a result of the new indication, following a scientific evaluation prior to authorization that it brought significant clinical benefit in comparison to existing therapies.

Press release at the following link:European Commission Authorizes Twice Yearly Yeytuo Lenacapavir for HIV Prevention