EC authorizes twice-yearly Yeytuo for HIV prevention

27 August 2025

US antivirals specialist Gilead Sciences (Nasdaq: GILD) yesterday 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 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, and was recommended for approval by the European Medicines Agency’s human medicines committee (CHMP) in July this year.

The prophylactic HIV drugs market is forecast to reach $54.7 billion during 2035, up from $35.2 billion in 2025.

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