Dr Reddy’s gets US FDA tentative approval for HIV prevention drug
The twice-yearly injectable lenacapavir aims to reduce HIV-1 risk for adults and adolescents weighing at least 35 kg.
Hyderabad-based Dr Reddy’s Laboratories has received tentative approval from the US Food and Drug Administration (USFDA) for its long-acting injectable lenacapavir. According to BusinessLine, the drug is intended for pre-exposure prophylaxis (PrEP) to lower the risk of sexually acquired HIV-1 in adults and adolescents who weigh at least 35 kg.
The approval was granted under the USFDA’s President’s Emergency Plan for AIDS Relief (PEPFAR) programme. This development follows a voluntary licence from Gilead Sciences in October 2024 and a September 2025 agreement with Unitaid, the Wits Reproductive Health and HIV Institute (Wits RHI), and the Clinton Health Access Initiative (CHAI).
The agreement aims to facilitate access to the injectable at $40 per person annually across 120 countries. Dr Reddy’s API and Services Chief Executive Officer Deepak Sapra said the approval validates their work and brings the company closer to providing this twice-yearly option to people in low- and middle-income countries.
Lenacapavir is a first-in-class HIV-1 capsid inhibitor that works by targeting multiple stages of the viral lifecycle. The company expects the first supplies to reach people by the end of 2026, with a wider rollout across eligible nations expected in 2027.
Wits RHI Director of Implementation Science Saiqa Mullick noted that while the drug has potential, countries require prepared health systems and engaged communities to successfully introduce and scale up such prevention options.
