US endorses inexpensive version of HIV prevention shot

The US Food and Drug Administration (FDA) on Monday approved a low-cost generic version of lenacapavir, a twice-yearly HIV prevention injection, bringing the drug closer to low-income countries, The PUNCH reports, citing AFP.

Indian manufacturer Dr. Reddy’s Laboratories and the global health initiative Unitaid announced the tentative approval.

The generic will cost $40 per person per year in 120 countries under a 2025 pricing deal between Unitaid, Wits RHI, the Clinton Health Access Initiative and Dr. Reddy’s. In the US, the original drug costs about $28,000 a year.

Lenacapavir was developed by Gilead Sciences and approved in June 2025 after proving more than 99.9 per cent effective in clinical trials.

“This is an extraordinary milestone for global health,” said Carmen Perez-Casas, Unitaid’s senior strategy lead for HIV.

She noted that an estimated 1.2 million people became infected with HIV last year.

Unitaid said more than 125,000 people in 10 African countries have already started using Gilead’s version of the drug.