EMA Validates Gilead’s Application for Twice-Yearly Lenacapavir as HIV Prevention

Gilead Sciences, Inc. announced that the European Medicines Agency (EMA) has validated for parallel accelerated review the company’s Marketing Authorization Application (MAA) and EU-Medicines for all (EU-M4all) application for lenacapavir—the company’s twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis (PrEP).

Based on the assessment of EMA’s Committee for Medicinal Products for Human Use (CHMP) that twice-yearly lenacapavir for prevention is a product of major interest for public health and therapeutic innovation, both applications will be assessed under an accelerated assessment review timeline.

The EU MAA will be reviewed by the CHMP under the centralized licensing procedure for all 27 Member States of the European Union, as well as Norway, Iceland and Liechtenstein. The EU-M4all application will be reviewed in parallel with the MAA and seeks a CHMP opinion that can be leveraged by national regulatory agencies outside the EU, including in low- and-lower-middle-income countries, to facilitate more expedited review processes in their respective countries and potentially accelerate access to lenacapavir for PrEP.

The EMA validation follows the announcement last week that the U.S. Food and Drug and Administration (FDA) accepted Gilead’s New Drug Applications (NDAs) for lenacapavir for PrEP and will assess them under priority review.

“Achieving another key regulatory milestone so soon after the U.S. FDA’s acceptance of our New Drug Applications for lenacapavir for PrEP underscores the great interest in how this medication, if approved, could help transform efforts to end the HIV epidemic globally,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences.

The EMA applications are supported by data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials conducted by Gilead. In PURPOSE 1 (NCT04994509), data showed twice-yearly lenacapavir demonstrated zero infections in the lenacapavir group and 100% risk reduction and superiority compared to background HIV incidence (bHIV) for the investigational use of HIV prevention in cisgender women. In PURPOSE 2 (NCT04925752), there were two HIV infections in the lenacapavir group, demonstrating 99.9% of participants in the lenacapavir group did not acquire HIV infection, a 96% risk reduction in HIV infections, and superiority compared to bHIV among a broad and geographically diverse range of cisgender men and gender-diverse people. In both trials, twice-yearly lenacapavir also demonstrated superiority of prevention of HIV infections when compared with once-daily oral Truvada® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) and was generally well-tolerated, with no significant or new safety concerns identified. Based in part on these trial results, Science Magazine in December 2024 named lenacapavir its 2024 “Breakthrough of the Year.”

Gilead is executing an access strategy, informed by global health advocates and organizations, that prioritizes speed and enables the most efficient paths for the regulatory review, approval of and access to lenacapavir for PrEP in regions around the world.

The use of lenacapavir for the prevention of HIV is investigational and is not approved anywhere globally.

There is currently no cure for HIV or AIDS.