Dr Reddy’s gets USFDA tentative approval for generic lenacapavir for HIV prevention
The approval, granted under the US President’s Emergency Plan for AIDS Relief (PEPFAR) programme, paves the way for the company to supply the twice-yearly HIV prevention injection in 120 countries covered by a voluntary licensing agreement with Gilead Sciences, the Hyderabad based Pharma giant said in a release.
Dr Reddy’s had entered into the voluntary licence agreement with Gilead in October 2024.
Subsequently, in September 2025, it joined hands with Unitaid, the Wits Reproductive Health and HIV Institute (Wits RHI) and the Clinton Health Access Initiative (CHAI) to support product development, regulatory processes and wider access.
Under the arrangement, the injectable is proposed to be made available at USD 40 per person per year across the 120 eligible countries.
The first supplies are expected to reach people by the end of 2026, with a wider rollout planned in 2027, Dr Reddy’s said.
Lenacapavir is administered twice a year and offers an alternative to more frequently administered pre-exposure prophylaxis (PrEP), particularly for people who face challenges with daily prevention medication.
Deepak Sapra, Chief Executive Officer, API and Services, Dr Reddy’s Laboratories, said the approval reflected the company’s capabilities in developing and manufacturing complex medicines at affordable prices.
Unitaid Executive Director Dr Philippe Duneton said the initiative had helped accelerate access to the drug, while CHAI CEO Dr Neil Buddy Shah described the twice-yearly injection as an important development in HIV prevention.
Wits RHI Director of Implementation Science Professor Saiqa Mullick said effective introduction would also require prepared health systems, trained healthcare providers and community engagement.
The company said the tentative approval would be followed by further steps towards wider availability, including WHO prequalification and national regulatory approvals.
Lenacapavir, originally developed by Gilead Sciences, is a long-acting HIV-1 capsid inhibitor.
HIV-negative status must be confirmed before initiating treatment and before subsequent injections, in accordance with the prescribing information.
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