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The U.S. 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, the Clinton Health Access Initiative (CHAI) and Dr. Reddy's.
Lenacapavir was first developed by U.S. pharmaceutical company Gilead Sciences and approved in June 2025 after proving more than 99.9% effective in large clinical trials.
"This is an extraordinary milestone for global health. For too long, people in lower- and middle-income countries have had to wait a decade or more to access breakthrough medicines already available elsewhere," Carmen Perez-Casas, Unitaid's senior strategy lead for HIV and pandemic preparedness, told AFP.
"With lenacapavir, we've reduced that gap to little more than a year. Having an FDA-approved generic at $40 per person per year—a price comparable to daily HIV prevention pills—is a remarkable achievement."
S. approval in 2012 but only work if taken consistently.
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