Gilead's Lenacapavir Receives EU Approval for HIV Prevention

Gilead Sciences' lenacapavir has been granted marketing authorization by the European Commission for HIV prevention. The approval is based on positive data from two Phase 3 studies, PURPOSE 1 and PURPOSE 2, which showed a 100% and 99.9% reduction in HIV infections, respectively. This follows FDA approval in June and WHO guidelines in July recommending twice-yearly lenacapavir as an HIV prevention option.

The European Commission (EC) has granted marketing authorization for Yeytuo® (lenacapavir), an 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. This authorization, based on positive data from two Phase 3 trials, marks a significant milestone in HIV prevention in Europe.

The EC authorization follows the U.S. Food and Drug Administration (FDA) approval of lenacapavir in June and the World Health Organization (WHO) guidelines in July, which recommended twice-yearly lenacapavir as an additional PrEP option. 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 due to 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. The CHMP adopted a positive opinion recommending Yeytuo for EC authorization in July.

The Phase 3 PURPOSE 1 and PURPOSE 2 trials demonstrated the efficacy of twice-yearly lenacapavir. In the PURPOSE 1 trial, zero HIV infections were reported among 2,134 participants, showing a 100% reduction in HIV infections compared to once-daily oral Truvada®. The PURPOSE 2 trial reported two HIV infections among 2,179 participants, demonstrating a 99.9% reduction in HIV infections compared to once-daily oral Truvada among a diverse group of cisgender men and gender-diverse people.

Lenacapavir is being developed as a foundation for potential future HIV therapies, offering long-acting oral and injectable options with various dosing frequencies. The journal Science named lenacapavir its 2024 “Breakthrough of the Year.”

Gilead Sciences, Inc. (Nasdaq: GILD) is executing a global access strategy to expedite regulatory review, approval, and access to twice-yearly lenacapavir for PrEP. The company has filed for regulatory review in several countries, including Australia, Brazil, Canada, South Africa, and Switzerland, and is preparing filings in Argentina, Mexico, and Peru. Additionally, Gilead is pursuing submissions to national regulatory authorities in low- and middle-income countries (LMIC) utilizing the EU-M4all opinion to facilitate accelerated review timelines.

References:
[1] https://www.morningstar.com/news/business-wire/20250825698635/european-commission-authorizes-twice-yearly-yeytuo-lenacapavir-for-hiv-prevention