Dr Reddy’s gets US FDA tentative nod for generic HIV prevention drug

Dr Reddy’s Laboratories on Monday said it has received tentative approval from the US Food and Drug Administration (FDA) for its generic version of injectable lenacapavir, a long-acting drug used to reduce the risk of HIV-1 infection.

The approval has been granted under the FDA’s President’s Emergency Plan for AIDS Relief (PEPFAR) programme. The drug is intended for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg.

Under an existing agreement, the injectable will be made available at $40 per person per year across 120 countries outside the US covered by Gilead Sciences’ voluntary licence. The first supplies are expected to reach countries before the end of 2026, with broader availability across eligible nations planned in 2027.

Lenacapavir is administered twice a year, offering an alternative to more frequently administered HIV prevention options. The approval builds on a voluntary licence granted by Gilead to Dr Reddy’s in October 2024.

In September 2025, Dr Reddy’s entered into an agreement with Unitaid, the Wits Reproductive Health and HIV Institute (Wits RHI) and the Clinton Health Access Initiative (CHAI) to support product development, accelerate the regulatory pathway and enable access to the injectable at an affordable price.

Regulatory milestone for affordable HIV prevention

“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,” Deepak Sapra, chief executive officer, API and Services, Dr Reddy’s Laboratories, said.

“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,” he added.

CHAI CEO Neil Buddy Shah said the approval brings the drug closer to being made available to millions more people at $40 a year.

“Getting a generic approved just 16 months after the originator, rather than a decade later, shows what’s possible when we prioritize access from the start. This should be the new standard for global health,” Shah said.