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Gilead Submits Marketing Authorization Applications to European Medicines Agency for Twice-Yearly Lenacapavir for HIV Prevention
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One Application Seeks European Commission Authorization; Other Application Would Help Facilitate Availability in Low- and Lower-Middle-Income Countries
Both Applications Will Be Assessed Under Accelerated Assessment Review Timeline Based on Agency's Belief in Potential Public Health Importance of Lenacapavir for HIV Prevention
Foster City, Calif., February 3, 2025 - Gilead Sciences, Inc. (Nasdaq: GILD) today announced the company has submitted a European Commission marketing authorization application (MAA) and an EU-Medicines for All (EU-M4all) application to the European Medicines Agency (EMA) as it seeks licenses for an investigational use of lenacapavir-the company's twice-yearly injectable HIV-1 capsid inhibitor-for the prevention of HIV as pre-exposure prophylaxis (PrEP).
The applications will undergo formal parallel assessments by the assigned Rapporteurs under an Accelerated Assessment review timeline, demonstrating the EMA's decision that lenacapavir for PrEP is of major interest for public health and therapeutic innovation.
The EU MAA for lenacapavir for PrEP will seek regulatory approval by the European Commission. The EU-M4all application aims to help facilitate availability of lenacapavir for PrEP in low- and lower-middle-income countries. Through the EU-M4all procedure, national regulatory authorities in these regions can leverage the EU opinion to expedite their review processes, potentially accelerating access to lenacapavir for PrEP.
The EMA applications are supported by data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials conducted by Gilead, and follow Gilead's New Drug Application submissions to the U.S. Food and Drug and Administration (FDA) in December 2024. 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. The safety and efficacy of this use has not been established by the U.S. FDA.
There is currently no cure for HIV or AIDS.
Full press release
https://www.gilead.com/company/company-statements/2025/gilead-submits-marketing-authorization-applications-to-european-medicines-agency-for-twice-yearly-lenacapavir-for-hiv-prevention
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