The US Food and Drug Administration (FDA) has granted tentative approval to a low-cost generic version of lenacapavir, a twice-yearly injection to prevent .
It marks a major step towards improving access to HIV prevention, with the generic drug expected to cost just $40 a year in low- and middle-income countries, compared with more than $28,000 for the branded version in the US.
Lenacapavir was developed by US pharmaceutical company Gilead Sciences, which first introduced the drug as an HIV treatment in 2022. In June 2025, Gilead received FDA approval for its branded version, Yeztugo, as a twice-yearly injection to prevent HIV.
This could make the drug available more quickly and affordably in 120 countries covered by Gilead’s voluntary licensing agreements, subject to national regulatory approvals.
The impact of lenacapavir
The low-cost version was developed by Dr. Reddy’s Laboratories. The approval follows a landmark pricing agreement announced in September 2025 between Unitaid, Wits RHI, CHAI and Dr. Reddy’s.
Dr Philippe Duneton, Executive Director at Unitaid, spoke about the impact of lenacapavir following the original drug’s approval for HIV prevention in 2025.
“With lenacapavir, we have helped shorten that timeline to just over a year. For young women in Africa, this translates into faster access to a groundbreaking HIV prevention option, with the potential to avert countless infections and drive meaningful change in the HIV response,” he said in a .
Lenacapavir “is almost 100 per cent effective at preventing HIV”
“For someone at risk of HIV, taking a pill every day to prevent a disease they don’t have is a hard thing to ask. Two injections a year, of a product that is almost 100 per cent effective at preventing HIV, changes that entirely,” said Dr Neil Buddy Shah, CEO of CHAI.
Lenacapavir is a long-acting injectable used to prevent HIV. Unlike daily PrEP pills, it is administered twice a year, meaning people at risk of HIV do not have to take a prevention pill every day.
Dr Shah said more than 125,000 people in Africa have already started on lenacapavir, “and today’s approval brings us closer to making it available to millions more for just $40 a year”.
“Getting a generic approved just 16 months after the originator, rather than a decade later, shows what’s possible when we prioritise access from the start. This should be the new standard for global health.”
Lenacapavir in the UK
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved lenacapavir for HIV prevention for adults in December 2025.
Lenacapavir is available to a small number of people under the who have developed resistance to other HIV prevention drugs.