US approves $40-a-year generic of twice-yearly HIV prevention shot
The US FDA gave tentative approval on Monday to Dr. Reddy's generic version of lenacapavir, a twice-yearly HIV prevention shot. It will cost $40 per person per year in 120 countries, compared with roughly $28,000 a year in the US.
The US Food and Drug Administration on Monday approved a low-cost generic of lenacapavir, a twice-yearly HIV prevention shot. The approval brings the drug closer to market in low-income countries, AFP reported. Dr. Reddy's Laboratories, the Indian company making the generic, and the global health initiative Unitaid announced the decision. The generic will sell for $40 per person per year in 120 countries. The price comes from a deal announced in September 2025 between Unitaid, the African health research institute Wits RHI, the Clinton Health Access Initiative (CHAI) and Dr. Reddy's. Unitaid said the FDA granted "tentative approval" under an accelerated pathway that lets sponsors use existing data. US company Gilead Sciences first developed lenacapavir. It was approved in June 2025 after large clinical trials showed it was more than 99.9 percent effective. Its high cost was a major obstacle: about $28,000 a year in the US, though insurance lowers what patients pay. In late 2024, Gilead gave voluntary licences to six generic makers, including Dr. Reddy's. Carmen Perez-Casas, Unitaid's senior strategy lead for HIV and pandemic preparedness, told AFP that people…
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