FDA Tentatively Approves First Generic Lenacapavir for HIV PrEP in Low- and Middle-Income Countries

The FDA has granted tentative approval to Dr. Reddy's generic twice-yearly lenacapavir for HIV pre-exposure prophylaxis (PrEP). This marks the first generic version of the drug, intended for 120 low- and middle-income countries at an estimated cost of $40 per person per year, with initial supplies expected by the end of 2026.