Dr Reddy’s Laboratories has received a tentative approval from the US Food and Drug Administration (USFDA) to its long-acting injectable lenacapavir for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kgs.
The approval was granted under the US FDA’s President’s Emergency Plan for AIDS Relief (PEPFAR) program.
“The US 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,’’ Deepak Sapra, Chief Executive Officer, API and Services, Dr. Reddy’s Laboratories said in a release on Monday.
The approval builds on the voluntary licence granted by Gilead Sciences to Dr. Reddy’s in October 2024, followed by an agreement with Unitaid, the Wits Reproductive Health and HIV Institute (Wits RHI) and the Clinton Health Access Initiative (CHAI) in September 2025 to support product development, accelerate the regulatory pathway and enable access to injectable lenacapavir at $40 per person per year across 120 countries in Gilead’s voluntary licence.
The FDA approval represents an important milestone for Hyderabad – based 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).
Lenacapavir is a first-in-class, long-acting HIV-1 capsid inhibitor with a novel mechanism of action. The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents.
While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross-resistance exhibited in vitro to other existing drug classes.
Published on November 2, 2026
