The United States Food and Drug Administration (FDA) has approved a low-cost 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 on Monday by Dr. Reddy’s Laboratories, the Indian pharmaceutical company manufacturing the generic version of lenacapavir, and Unitaid, a global health initiative.
Under a pricing agreement announced in September 2025 between Dr. Reddy’s, Unitaid, the South African health research institute Wits RHI and the Clinton Health Access Initiative (CHAI), the generic injection will be available for $40 per person annually in 120 countries.
Reacting to the development, Deepak Sapra, Chief Executive Officer of Pharmaceutical Services and Active Pharmaceutical Ingredients at Dr. Reddy’s, described the approval as a significant achievement for the company.
“This is a moment of immense pride for all of us at Dr. Reddy’s,” Sapra said 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.”
Also commenting, Unitaid’s Executive Director, Philippe Duneton, said the development demonstrated how early investment in medical innovation could accelerate access to life-saving treatments.
“Unitaid’s early risk-taking is helping shorten the time between a scientific breakthrough and real access in countries,” he said.
Lenacapavir was originally developed by US 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.
The twice-yearly injection offers an alternative to daily oral pre-exposure prophylaxis (PrEP) pills, which have been available since receiving US approval in 2012 but require consistent use to provide effective protection against HIV.
Unlike traditional vaccines, lenacapavir does not train the immune system to recognise and fight HIV. Instead, it works by targeting the virus’s capsid, a protein shell that protects its genetic material.
Its long-acting formulation allows individuals to receive HIV prevention protection through two injections annually, potentially making adherence easier than taking daily medication.
However, the drug’s high cost has been a major obstacle to wider access. In the United States, the branded version costs approximately $28,000 annually, although insurance coverage can reduce patients’ out-of-pocket expenses.
In late 2024, Gilead granted voluntary licences to six generic manufacturers, including Dr. Reddy’s, allowing them to produce more affordable versions of the drug for eligible countries.
According to Unitaid, more than 125,000 people across 10 early-adopter African countries had already started using Gilead’s lenacapavir before the generic version became available.
The FDA approval was granted under the US President’s Emergency Plan for AIDS Relief (PEPFAR), Dr. Reddy’s said.
The development is expected to improve access to long-acting HIV prevention, particularly in countries where the cost of branded medication has limited availability.
AFP
