FDA Tentatively Approves Generic HIV PrEP Drug for Developing Nations

The FDA has tentatively approved the first generic version of lenacapavir, a twice-yearly injectable for HIV preexposure prophylaxis (PrEP), developed by Dr. Reddy's Laboratories. This approval targets 120 low- and middle-income countries under Gilead Sciences' licensing program, aiming to provide the drug at an estimated $40 per person annually, with initial supplies expected by late 2026. This could significantly expand access to HIV prevention.