US FDA grants tentative approval to generic lenacapavir

The US Food and Drug Administration has granted tentative approval to a low-cost generic version of lenacapavir, a twice-yearly HIV prevention injection, in a decision that could widen access in 120 countries, according to Punch.

Punch reported that Dr Reddy's Laboratories, the Indian maker of the generic, and Unitaid, a global health initiative, announced the approval on Monday. The generic will be sold 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 and Dr Reddy's.

Lenacapavir was developed by US pharmaceutical company Gilead Sciences and approved in June 2025 after clinical trials showed it was more than 99.9 percent effective, according to Punch. A twice-yearly injectable can be a more practical way to deliver HIV pre-exposure prophylaxis than daily pills, which work only if taken consistently. The drug's US price of roughly $28,000 per year had been a barrier to wider access.

Carmen Perez-Casas, Unitaid's senior strategy lead for HIV and pandemic preparedness, told AFP that the approval was 'an extraordinary milestone for global health.' She said lower- and middle-income countries have often waited a decade or more for breakthrough medicines, and that the gap for lenacapavir had been reduced 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,' she said, according to Punch.

Deepak Sapra, CEO of Pharmaceutical Services and API at Dr Reddy's, said in a statement that the approval was 'a moment of immense pride' for the company, Punch reported.

Unitaid said more than 125,000 people in 10 early adopter African countries had already started Gilead's lenacapavir before the generic became available. Perez-Casas said about 1.2 million people acquired HIV last year. 'The demand is high, and we cannot afford to lose momentum,' she said.

Gilead granted voluntary licences for lenacapavir to six generic manufacturers, including Dr Reddy's, in late 2024. The journal Science named lenacapavir its Breakthrough of the Year in 2024, citing research into HIV's capsid protein, which the drug targets.