Dr Reddy's gets USFDA tentative nod for HIV prevention drug

New Delhi Nov 2 (PTI) Dr Reddy’s Laboratories on Monday said it has received tentative approval from the US health regulator for its injectable lenacapavir used for reducing HIV-1 risk.

The tentative approval was granted under the US Food and Drug Administration’s (FDA) President’s Emergency Plan for AIDS Relief (PEPFAR) programme, the drugmaker said in a statement.

Under an existing agreement, the injectable will be made available at USD 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 a broader rollout across eligible nations planned in 2027.

The development follows a voluntary licence granted by Gilead Sciences

to Dr Reddy’s in October 2024, and a subsequent partnership in September 2025 with Unitaid, the Wits Reproductive Health and HIV Institute (Wits RHI), and the Clinton Health Access Initiative (CHAI) to accelerate the regulatory and product development pathway.

Deepak Sapra, Chief Executive Officer, API and Services, Dr Reddy’s Laboratories, said the approval validates the company’s scientific and manufacturing capabilities and brings it closer to making the twice-yearly HIV prevention option available across low- and middle-income nations.

The FDA decision provides a regulatory basis for further steps, including World Health Organization (WHO) pre-qualification and national regulatory approvals. PTI TRB BAL

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