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 in poorer countries have often waited a decade or more for new medicines. She said lenacapavir cut that gap to little more than a year. She called the $40 price, comparable to daily prevention pills, "a remarkable achievement". Deepak Sapra of Dr. Reddy's said it was "a moment of immense pride" for the company.
A shot every six months can work better than daily PrEP pills, which only protect if taken consistently. Oral PrEP pills won US approval in 2012. Cabotegravir, a shot given every two months, was approved in 2021. The journal Science named lenacapavir its "Breakthrough of the Year" in 2024. The drug targets HIV's capsid protein, the shell around the virus's genetic material.
HIV has killed more than 40 million people in four decades, AFP reported. According to Unitaid, more than 125,000 people in 10 early adopter African countries have already started Gilead's branded shot. Perez-Casas said an estimated 1.2 million people acquired HIV last year. She said the real work now lies in the rollout, and that Unitaid is working with governments and partners on country-led programmes.