Dr Reddy’s gets USFDA nod for first generic twice-yearly injectable HIV prevention drug Lenacapavir | Hyderabad News

A file shot of Dr Reddy’s Labs headquarters in Hyderabad.

Hyderabad: Dr Reddy’s Laboratories said Monday US Food and Drug Administration has granted tentative approval for its twice-yearly injectable lenacapavir for pre-exposure prophylaxis, or PrEP, to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg.The approval, issued under USFDA’s President’s Emergency Plan for AIDS Relief (PEPFAR) programme, moves the long-acting HIV prevention medicine closer to use in 120 countries outside the United States covered by Gilead Sciences’ voluntary licence.Dr Reddy’s said the first supplies are expected to reach countries before the end of 2026, with broader availability in eligible markets in 2027.Lenacapavir is a first-in-class HIV-1 capsid inhibitor designed to act at multiple stages of the virus lifecycle. Gilead granted Dr Reddy’s a voluntary licence in October 2024. In September 2025, Unitaid, Wits Reproductive Health (Wits RHI) and HIV Institute and Clinton Health Access Initiative (CHAI) agreed to support product development, speed regulatory work and enable access at $40 per person per year.Deepak Sapra, chief executive officer for API and Services at Dr Reddy’s, said the approval validates the company’s work to develop and manufacture a complex long-acting injectable at an affordable price. Unitaid, CHAI and Wits RHI said accelerated generic approval could help expand prevention options, particularly for underserved populations.“Unitaid’s early risk-taking is helping shorten the time between a scientific breakthrough and real access in countries,” said Dr Philippe Duneton, executive director, Unitaid, saying lenacapavir could help young women in Africa avert infections.“For someone at risk of HIV, taking a pill every day to prevent a disease they don’t have is a hard thing to ask,” said Dr Neil Buddy Shah, CEO, CHAI, calling two injections yearly “almost 100% effective” and a “new standard for global health.”“Generic lenacapavir has the potential to transform HIV prevention,” said Prof Saiqa Mullick of Wits RHI, pointing out that countries need ready health systems, trained providers and engaged communities.World Health Organization recommends twice-yearly lenacapavir for HIV prevention. Dr Reddy’s said wider rollout still requires WHO prequalification and national regulatory approvals with HIV-negative status to be confirmed before initiation and before each subsequent injection.