FOSTER CITY, Calif., August 26, 2025 — Gilead Sciences, Inc. (Nasdaq: GILD) today announced that 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 35 kg. 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.
Read the full company press release here.
Source : Gilead Sciences, Inc.
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