Dr. Reddy’s secures U.S. FDA tentative nod for HIV drug lenacapavir

Generic drugmaker Dr. Reddy’s Laboratories has received U.S. Food and Drug Administration (U.S. FDA) tentative approval for twice-yearly injectable HIV prevention drug lenacapavir.

The approval was granted under the U.S. FDA’s President’s Emergency Plan for AIDS Relief (PEPFAR) programme. It is an important milestone and reflects the company’s capabilities in developing and manufacturing complex medicines, Dr. Reddy’s said on Monday.

First supplies are expected to reach people by December with broader rollout across eligible countries expected in 2027, it said, announcing the tentative approval for 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 77 pounds (35 kg).

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. The agreement was to support product development, accelerate regulatory pathway and enable access to injectable lenacapavir at $40 per person per year across 120 countries in Gilead’s voluntary licence.

“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…” CEO-API and Services Deepak Sapra said.

The U.S. FDA approval provides an important regulatory basis for the remaining steps towards wider availability, including WHO prequalification and national regulatory approvals, the company said.

CEO of CHAI Neil Buddy Shah said “getting a generic approved just 16 months after the originator shows what’s possible when we prioritise access from the start.”

“Generic lenacapavir has the potential to transform HIV prevention… but an affordable drug alone is not enough. Countries need health systems that are ready to deliver new prevention options, providers who are confident in offering them and communities that are engaged as partners in their introduction and scale-up,” said Saiqa Mullick, Director of Implementation Science at Wits RHI, University of the Witwatersrand.