FDA authorises generic HIV prevention injection
By the AFREEQUE newsroom, based on IOL and Capital FM
The US FDA has granted provisional authorisation to Dr Reddy’s Laboratories for the first generic version of lenacapavir, a twice-yearly HIV prevention injection, IOL and Capital FM report. The product could be offered in 120 low- and middle-income countries at a projected price of $40 a year, according to Capital FM. First deliveries are expected by the end of 2026.
The FDA’s provisional authorisation is a regulatory step, but countries will still need to obtain their own approvals and prepare to introduce the product. Partners are working with governments, communities, the Global Fund, the US Bureau of Global Health Security and Diplomacy, the Gates Foundation and other organisations to support the rollout, according to Capital FM.
Capital FM reports that more than 125,000 people in 10 African countries that adopted the product early are already using Gilead’s lenacapavir. The generic is covered by voluntary licences granted by Gilead to six manufacturers in 2024. Its application combined HIV prevention and treatment indications and received a priority review from the FDA.
