Press release
U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review
– If Approved, Lenacapavir Would Be the First and Only Twice-Yearly HIV Prevention Choice – – FDA to Review Applications Under Priority Review, with a PDUFA
About this update from Gilead Sciences, Inc.
[{"type":"text","content":"\n– If Approved, Lenacapavir Would Be the First and Only Twice-Yearly HIV Prevention Choice –\n\n– FDA to Review Applications Under Priority Review, with a PDUFA Date of June 19, 2025 –\n\n– Gilead Also Recently Submitted Applications for Lenacapavir for PrEP to the European Medicines Agency That Will Be Reviewed Under Accelerated Assessment Review Timeline –\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nGilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir—the company’s twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis (PrEP).\n\nThe FDA will review the applications under priority review and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 19, 2025. Acceptance of the NDAs follows receipt of Breakthrough Therapy Designation for lenacapavir for PrEP granted by the FDA in October 2024. The Breakthrough Therapy Designation process is intended to expedite the development and regulatory review of investigational treatments for serious or life-threatening conditions that, based on preliminary clinical evidence, have the potential to substantially improve clinical outcomes compared with available therapy.\n\n“Today, we are one step closer to introducing the first-ever twice-yearly HIV prevention choice that could, if approved, help transform the landscape for individuals who need or want additional prevention options that better fit into their lives,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. “We’re excited about the potential of lenacapavir to make a real difference in HIV prevention in the U.S. and around the world, supporting the broader goal of ending the HIV epidemic for everyone, everywhere.”\n\nThe NDAs are based on 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 a...