Dr. Reddy’s Laboratories Ltd. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its long-acting injectable lenacapavir for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1. The authorization covers adults and adolescents weighing at least 77 pounds (35 kg) under the U.S. FDA’s President’s Emergency Plan for AIDS Relief (PEPFAR) program

This approval follows a voluntary licensing agreement granted by Gilead Sciences to Dr. Reddy’s Laboratories in October 2024. The initiative was further strengthened in September 2025 through a joint partnership with Unitaid, the Wits Reproductive Health and HIV Institute, and the Clinton Health Access Initiative. This collaboration accelerates product development and regulatory pathways, ensuring that injectable lenacapavir is accessible at an affordable cost of US$40 per person annually across 120 low- and middle-income nations covered under the licence.

The FDA approval represents an important milestone for Dr. Reddy’s Public Health Access portfolio and reflects the company’s capabilities in developing and manufacturing complex medicines. The first supplies are expected to reach people by the end of 2026, with broader rollout across eligible countries expected in 2027.

HIV continues to pose a significant global public health challenge, with gaps remaining in access to and uptake of effective prevention options. Long-acting lenacapavir, administered twice a year, provides an additional prevention option for people who may face challenges with more frequently administered pre-exposure prophylaxis (PrEP).

Deepak Sapra, Chief Executive Officer, API and Services, Dr. Reddy’s Laboratories Ltd., said: “This is a moment of immense pride for all of us at Dr. Reddy’s. 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. The U.S. FDA approval validates that work and brings us a significant step closer to making this twice-yearly HIV prevention option available to people across low- and middle-income countries. We are grateful to Gilead for the voluntary licence and to Unitaid, Wits RHI and CHAI for their support in accelerating this journey.”

Dr. Philppe Duneton, Executive Director at Unitaid said: “Unitaid’s early risk-taking is helping shorten the time between a scientific breakthrough and real access in countries. With best-in-class HIV treatment, we delivered in four years what used to take ten. Now, with lenacapavir, we have helped shorten that timeline to just over a year. For young women in Africa, this translates into faster access to a groundbreaking HIV prevention option, with the potential to avert countless infections and drive meaningful change in the HIV response.”