Grace Abayomi
The United States Food and Drug Administration (FDA) has approved an affordable generic version of a twice-yearly HIV prevention injection, bringing the drug closer to becoming accessible in low-income countries.
The development was announced on Monday by Dr. Reddy’s Laboratories, an Indian pharmaceutical company responsible for producing the generic version of lenacapavir, alongside global health organisation Unitaid.
Under a pricing agreement announced in September 2025 involving Dr. Reddy’s, Unitaid, South Africa’s Wits RHI and the Clinton Health Access Initiative (CHAI), the generic injection will be supplied at $40 per person annually across 120 countries.
Reacting to the approval, Deepak Sapra, Chief Executive Officer of Pharmaceutical Services and Active Pharmaceutical Ingredients at Dr. Reddy’s, described the achievement as a significant milestone for the company.
He explained that developing and manufacturing a complex, long-acting injectable medication such as lenacapavir at an affordable price required considerable scientific expertise and manufacturing capacity to address an urgent global health need.
Unitaid’s Executive Director, Philippe Duneton, also welcomed the development, noting that the organisation’s early investment and willingness to take risks were helping reduce the time between scientific breakthroughs and their availability to people in countries that need them.
Lenacapavir was originally developed by American pharmaceutical company Gilead Sciences and received approval in June 2025 after clinical trials demonstrated an effectiveness rate of more than 99.9 per cent in preventing HIV infection.
The injection is administered twice a year and offers an alternative to daily oral pre-exposure prophylaxis (PrEP) medication. Unlike conventional vaccines, it does not work by training the immune system but provides long-acting protection against HIV.
Although daily PrEP pills received approval in the United States in 2012, their effectiveness depends largely on consistent use, making the twice-yearly injection a potentially more convenient prevention option.
However, the high cost of lenacapavir has remained a major barrier to wider access. The medication costs approximately $28,000 annually in the United States, although insurance coverage can reduce the amount paid by patients.
The introduction of the generic version is expected to significantly improve affordability, particularly in countries with limited healthcare resources.
In late 2024, Gilead granted voluntary licences to six generic drug manufacturers, including Dr. Reddy’s Laboratories, allowing them to produce more affordable versions of the medication.
Unitaid disclosed that more than 125,000 people across 10 early-adopter African countries had already commenced using Gilead’s lenacapavir even before generic versions became available.
Dr. Reddy’s said the latest approval was granted under the US President’s Emergency Plan for AIDS Relief (PEPFAR), a programme supporting efforts to prevent and combat HIV/AIDS globally.
