Overview
- Dr. Reddy’s generic lenacapavir received tentative approval from the U.S. Food and Drug Administration on Monday, enabling its use in medicines purchased with U.S. global health funds.
- The drug will be sold at about $40 per person per year under an agreement brokered by Unitaid, CHAI and Wits RHI and is intended for supply in 120 low- and middle-income countries.
- Initial shipments are expected to start in some countries within weeks, with Zambia among the first targets before the end of 2026 and hopes to reach more places around World AIDS Day.
- The approval is tentative because Gilead’s brand product remains under U.S. patent protection so the generic cannot be sold in the U.S., and wider rollout still requires other manufacturers’ approvals, national regulatory steps and funding for procurement.
- Lenacapavir is a twice-yearly injectable PrEP that showed near-elimination of new infections in trials, but safe scale-up will require routine HIV testing before each injection to avoid treating people with undiagnosed infection and driving drug resistance.