WASHINGTON, United States (AFP) — The United States (US) Food and Drug Administration on Monday approved a low-cost version of a twice-yearly HIV prevention shot, bringing the breakthrough drug closer to market in low-income countries.

The 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 $40 per person per year in 120 countries, under a pricing agreement announced in September 2025 between Dr Reddy’s and Unitaid, the African health research institute Wits RHI, and the Clinton Health Access Initiative (CHAI).

“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.

“Developing and manufacturing a complex long-acting injectable like lenacapavir at an affordable price required strong scientific capabilities and manufacturing expertise to address an urgent access need.”

“Unitaid’s early risk-taking is helping shorten the time between a scientific breakthrough and real access in countries,” added Philippe Duneton, Unitaid’s executive director.

Lenacapavir was first developed by US pharmaceutical company Gilead and approved in June 2025 after proving more than 99.9 per cent effective in large clinical trials.

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, over 125,000 people in 10 early adopter African countries have already started Gilead’s lenacapavir,” Unitaid’s statement said.

The approval was granted under the US FDA’s President’s Emergency Plan for AIDS Relief (PEPFAR) program, Dr Reddy’s said.