The US Food and Drug Administration on Monday approved a low-cost version of a twice-yearly HIV prevention shot, bringing the breakthrough drug nearer to market in low-income nations.
The approval was introduced by Dr Reddy’s Laboratories, the Indian maker of the generic version of lenacapavir, and by Unitaid, a world well being initiative.
The generic will probably be accessible for $40 per individual per yr in 120 nations, below a pricing settlement introduced in September 2025 between Dr Reddy’s and Unitaid, the African well being analysis institute Wits RHI, and the Clinton Health Access Initiative (CHAI).
“This is a moment of immense pride for all of us at Dr Reddy’s,” mentioned Deepak Sapra, CEO of Pharmaceutical Services and API at Dr Reddy’s, in a press release.
“Developing and manufacturing a complex long-acting injectable like lenacapavir at an affordable price required strong scientific capabilities and manufacturing expertise to address an urgent access need.”
“Unitaid’s early risk-taking is helping shorten the time between a scientific breakthrough and real access in countries,” added Philippe Duneton, Unitaid’s govt director.
Lenacapavir was first developed by US pharmaceutical firm Gilead and approved in June 2025 after proving greater than 99.9 per cent efficient in massive scientific trials.
A twice-yearly injectable that’s akin to a vaccine – albeit with out coaching the immune system – could be a more practical approach to administer HIV pre-exposure prophylaxis (PrEP) than day by day drugs, which first gained US approval in 2012 however solely work if taken persistently.
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