Gilead Sciences, Inc. (Nasdaq: GILD) announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) and EU-Medicines for All (EU-M4all) application for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor for pre-exposure prophylaxis (PrEP). The applications will be assessed in parallel under an accelerated review timeline, recognizing lenacapavir’s potential public health impact.

The EU MAA will undergo centralized review across 27 EU Member States, along with Norway, Iceland, and Liechtenstein, while the EU-M4all application aims to facilitate expedited approvals in low- and lower-middle-income countries. This development follows the U.S. FDA’s acceptance of New Drug Applications (NDAs) for lenacapavir under priority review.

The EMA’s validation is supported by results from Phase 3 PURPOSE 1 and PURPOSE 2 trials, which demonstrated high efficacy in reducing HIV infection rates. In PURPOSE 1, the lenacapavir group showed zero infections, while PURPOSE 2 recorded a 96% risk reduction in HIV infections compared to background HIV incidence.

If approved, lenacapavir could transform global HIV prevention efforts as a long-acting, twice-yearly PrEP option, offering an alternative to daily oral Truvada (F/TDF). Gilead is actively working on an access strategy to expedite global availability.

Lenacapavir for HIV prevention remains investigational and has not yet received approval worldwide.

Source: Gilead Sciences, "European Medicines Agency Validates Gilead’s Marketing Authorization Application for Twice-Yearly Lenacapavir for HIV Prevention," February 24, 2025.