A low-cost generic of Gilead’s lenacapavir, a twice-yearly HIV prevention shot, won tentative FDA approval and will cost $40 per person a year in 120 countries.
WASHINGTON: The US Food and Drug Administration on Monday approved a low-cost version of a twice-yearly HIV prevention shot, bringing the breakthrough drug closer to market in low-income countries.
The tentative approval was announced by Dr. Reddy’s Laboratories, the Indian maker of the generic version of lenacapavir, and by Unitaid, a global health initiative.
The generic will be available for $40 per person per year in 120 countries, under a pricing agreement announced in September 2025 between Unitaid, the African health research institute Wits RHI, and the Clinton Health Access Initiative (CHAI) and Dr. Reddy’s.
