US FDA grants tentative nod to Dr Reddy's twice-yearly HIV prevention drug

Dr Reddy’s Laboratories has received tentative approval from the US Food and Drug Administration (FDA) for its generic version of lenacapavir, a long-acting injectable drug administered twice a year to prevent HIV infection.

The approval is expected to accelerate access to the drug across 120 countries outside the US under a voluntary licensing agreement with its innovator, Gilead Sciences.

The approval has been granted under the FDA’s President’s Emergency Plan for AIDS Relief (PEPFAR) programme. Under an existing agreement with Unitaid, the Wits Reproductive Health and HIV Institute (Wits RHI) and the Clinton Health Access Initiative (CHAI), the injectable is expected to be made available at $40 per person annually across the 120 countries covered by Gilead’s voluntary licence.

The first supplies are expected to reach countries before the end of 2026, with a broader rollout across eligible markets in 2027, the company said on Monday.

The development follows a voluntary licence granted by Gilead to Dr Reddy’s in October 2024. In September 2025, the Hyderabad-based drugmaker entered into an agreement with Unitaid, Wits RHI and CHAI to support product development, expedite regulatory approvals and facilitate affordable access to the drug.

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Lenacapavir offers an alternative to existing pre-exposure prophylaxis (PrEP) options, which often require more frequent administration. Given twice a year, the long-acting injectable is intended to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg.

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

The FDA's tentative approval marks a significant regulatory milestone, although wider availability will also depend on further steps, including World Health Organization (WHO) prequalification and national regulatory approvals in individual markets.

The approval comes amid efforts to expand access to long-acting HIV prevention options, particularly in low- and middle-income countries, where daily medication can pose challenges to adherence and uptake.

Unitaid said its support had helped accelerate the timeline for generic lenacapavir, bringing the approval process closer to the originator's launch rather than the decade-long gap often seen in generic drug development.

“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,” said Philippe Duneton, executive director of Unitaid.

The WHO has also recommended twice-yearly lenacapavir in its HIV prevention guidelines. However, health systems will need to prepare for its introduction through provider training, community engagement and wider delivery infrastructure, Wits RHI said.

Dr Reddy’s said the development strengthens its public health access portfolio and demonstrates its capabilities in developing and manufacturing complex medicines. The company is working with its partners to support product introduction and generate real-world evidence to guide its rollout across underserved populations.