The United States Food and Drug Administration, FDA, has approved a cheaper generic version of a twice-yearly HIV prevention injection, paving the way for wider access to the drug in low-income countries.
The approval was announced by Indian pharmaceutical company, Dr. Reddy’s Laboratories, which developed the generic version of lenacapavir, alongside global health organisation, Unitaid.
Under a pricing agreement reached in September 2025, the injection is expected to cost 40 dollars per person annually across 120 countries.
The agreement involved Dr. Reddy’s Laboratories, Unitaid, South Africa’s Wits Reproductive Health and HIV Institute, and the Clinton Health Access Initiative.
The Chief Executive Officer of Pharmaceutical Services and Active Pharmaceutical Ingredients at Dr. Reddy’s, Deepak Sapra, described the approval as a major achievement, noting that developing an affordable long-acting injectable required significant scientific and manufacturing expertise.
Similarly, Unitaid’s Executive Director, Philippe Duneton, said the initiative would help bridge the gap between medical breakthroughs and access to affordable treatment in countries that need them most.
Lenacapavir was originally developed by American pharmaceutical company Gilead Sciences and received approval in June 2025 after clinical trials demonstrated more than 99.9 per cent effectiveness in preventing HIV infection.
Unlike traditional pre-exposure prophylaxis, PrEP, which requires daily medication, lenacapavir is administered through an injection twice a year, offering a more convenient prevention option and reducing the risk of missed doses.
However, its high cost, estimated at about 28,000 dollars annually in the United States, had remained a major barrier to wider access, particularly in low-income countries.
Gilead had earlier granted voluntary licences to six generic manufacturers, including Dr. Reddy’s, to support the production of more affordable versions of the drug.
Unitaid disclosed that more than 125,000 people across 10 African countries had already started using Gilead’s version of lenacapavir under early access programmes.
The latest approval was granted under the United States President’s Emergency Plan for AIDS Relief, PEPFAR, programme, according to Dr. Reddy’s Laboratories.
