HIV prevention shot generic gets tentative US approval

The US Food and Drug Administration has tentatively approved a low-cost generic version of lenacapavir, a twice-yearly HIV prevention shot intended for use in lower-income countries.

The approval was announced on November 2 by Indian drugmaker Dr. Reddy's Laboratories and Unitaid, a global health initiative. They said the generic will be available for $40 per person per year in 120 countries under a pricing agreement announced in September 2025 with Unitaid, Wits RHI and the Clinton Health Access Initiative.

Lenacapavir was developed by Gilead Sciences and approved in June 2025 after large clinical trials found it was more than 99.9 percent effective. The injectable drug is used as HIV pre-exposure prophylaxis, or PrEP, and is given twice a year.

Unitaid said the FDA granted tentative approval under an accelerated pathway that allows sponsors to use existing data. It said more than 125,000 people in 10 early adopter African countries have already started Gilead's version of lenacapavir.

Unitaid official Carmen Perez-Casas said the main challenge is now moving from approval to rollout. She said about 1.2 million people acquired HIV last year, while a medicine offering near-100 percent protection with two injections a year is now available.