The tentative approval was announced by Dr Reddy’s Laboratories, the Indian maker of the generic version of lenacapavir, and by Unitaid, a global health initiative.
The generic will be available for US$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, and the Clinton Health Access Initiative (CHAI) and Dr Reddy’s.
Lenacapavir was first developed by US pharmaceutical company Gilead Sciences and approved in June 2025 after proving more than 99.9 percent effective in large clinical trials.
“This is an extraordinary milestone for global health. For too long, people in lower- and middle-income countries have had to wait a decade or more to access breakthrough medicines already available elsewhere,” said Carmen Perez-Casas, Unitaid’s senior strategy lead for HIV and pandemic preparedness.
“With lenacapavir, we’ve reduced that gap to little more than a year. Having an FDA-approved generic at US$40 per person per year – a price comparable to daily HIV prevention pills – is a remarkable achievement.”
A twice-yearly injectable that is akin to a vaccine – albeit without training the immune system – can be a more effective way to administer HIV preexposure prophylaxis (PrEP) than daily pills, which first won US approval in 2012 but only work if taken consistently.
But lenacapavir’s high cost – roughly $28,000 per year in the US, though insurance lowers what patients pay – was a major obstacle to its becoming a game-changer against a disease that has killed over 40 million people in four decades.
In late 2024, Gilead granted voluntary licenses for lenacapavir to six generic manufacturers, including Dr Reddy’s.
Even before generic availability, more than 125,000 people in 10 early adopter African countries have already started Gilead’s lenacapavir, Unitaid’s statement said.
“This is a moment of immense pride for all of us at Dr Reddy’s,” said Deepak Sapra, CEO of Pharmaceutical Services and API at Dr Reddy’s, in a statement.
The generic was granted “tentative approval” by the FDA, Unitaid said, under an accelerated pathway that allows sponsors to use existing data.
Lenacapavir was named “Breakthrough of the Year” in 2024 by the prestigious journal Science, which hailed the basic research underpinning the drug, specifically a new understanding of HIV’s capsid protein, which forms a protective shell around the virus’s genetic material and which lenacapavir targets.
An HIV infection once condemned patients to Aids (Acquired Immunodeficiency Syndrome), when the immune system is so damaged that everyday germs make people very sick.
The first antiretrovirals that could fully suppress HIV and stave off Aids were developed in 1996, with current generations even better, allowing people to live normal life spans while managing their chronic infection.
Oral PrEP pills came along in 2012, and before lenacapavir, a PrEP drug called cabotegravir was approved in 2021 requiring shots every two months.
Perez-Casas said the real work for lenacapavir was still ahead, in moving from approval to rollout.
“An estimated 1.2 million people acquired HIV last year, even as we now have a medicine offering near-100 percent protection with just two injections a year,” she said.
“The demand is high, and we cannot afford to lose momentum. Unitaid is already working with governments and partners to support country-led rollouts, ensuring that communities play a central role in bringing this breakthrough to the people who need it most.” (AFP)
