THE U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for the first-ever twice-yearly injectable HIV prevention therapy. This investigational treatment, a long-acting capsid inhibitor, is now under priority review with a Prescription Drug User Fee Act (PDUFA) action date set for June 19, 2025. If approved, it would become the only biannual HIV pre-exposure prophylaxis (PrEP) option available.
The FDA’s priority review follows the Breakthrough Therapy Designation granted in October 2024, which accelerates the evaluation of treatments with the potential to significantly improve patient outcomes. The application is supported by Phase 3 data from the PURPOSE 1 and PURPOSE 2 trials, which demonstrated exceptional efficacy in preventing HIV infection among diverse populations.
PURPOSE 1 (NCT04994509) investigated the therapy in cisgender women, showing a 100% risk reduction with zero infections in the treatment group. PURPOSE 2 (NCT04925752) assessed efficacy in cisgender men and gender-diverse individuals, with a 96% risk reduction compared to background HIV incidence. Additionally, the injectable was superior in preventing HIV infections when compared to once-daily oral Truvada® (emtricitabine/tenofovir disoproxil fumarate) and exhibited a strong safety profile with no significant new concerns.
Beyond the U.S., regulatory efforts are underway in Europe, where an application for marketing authorization has been submitted. The EU-M4all procedure aims to expedite access in lower-income countries, aligning with broader global HIV prevention initiatives.
While this long-acting PrEP option remains investigational, its potential approval could mark a significant advancement in HIV prevention strategies. Healthcare professionals will be closely watching for the FDA’s decision, which may reshape the landscape of HIV prophylaxis and expand options for at-risk populations.
Reference: Gilead. U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review. February 18, 2025. Available at: https://www.gilead.com/news/news-details/2025/us-fda-accepts-gileads-new-drug-applications-for-twice-yearly-lenacapavir-for-hiv-prevention-under-priority-review/. Last accessed: February 18, 2025.
