Gilead Sciences Receives FDA Approval for Sunlenca as HIV Pre-Exposure Prophylaxis

Gilead Sciences today announced that the FDA has approved Sunlenca (lenacapavir) as twice-yearly subcutaneous injection for HIV pre-exposure prophylaxis (PrEP) in adults and adolescents at risk for HIV. The approval was based on results from the Phase 3 PURPOSE 1 and PURPOSE 2 trials, which demonstrated exceptional HIV prevention efficacy. In PURPOSE 1, lenacapavir achieved 100% efficacy in cisgender women. In PURPOSE 2, lenacapavir demonstrated 96% reduction in HIV incidence compared to daily oral F/TDF. This approval provides individuals at risk for HIV a new highly effective, long-acting PrEP option with twice-yearly dosing.