Dr Reddy’s Laboratories has received tentative approval from the US Food and Drug Administration (FDA) 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 35 kg.
The approval was granted under the US President’s Emergency Plan for AIDS Relief (PEPFAR) programme.
The regulatory milestone follows a voluntary licence granted by Gilead Sciences 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 regulatory approval and facilitate access to injectable lenacapavir at USD 40 per person per year across 120 countries covered by Gilead’s voluntary licence.
With the approval, the first supplies are expected to reach people by the end of 2026, with broader rollout across eligible countries anticipated in 2027.
Expanding access to long-acting HIV prevention
HIV remains a major global public health challenge, with persistent gaps in access to and uptake of effective prevention options. Administered twice a year, long-acting lenacapavir offers an additional prevention option for people who may face challenges with more frequently administered PrEP regimens.
“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, CEO, API and Services, Dr Reddy’s Laboratories.
“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,” he added.
Dr Philppe Duneton, executive director of Unitaid, said the faster availability of lenacapavir could benefit young women in Africa and help prevent new infections.
Dr Neil Buddy Shah, CEO of CHAI, said the twice-yearly injection could offer a more convenient prevention option for people at risk of HIV who find daily oral PrEP challenging.
He said that more than 125,000 people in Africa had already started using lenacapavir, and that the generic approval brings the drug closer to becoming available to millions more at a cost of just USD 40 per person per year.
“Getting a generic approved just 16 months after the originator, rather than a decade later, shows what’s possible when we prioritise access from the start. This should be the new standard for global health,” he added.
Professor Saiqa Mullick, Director of Implementation Science at Wits RHI, University of the Witwatersrand, said an affordable drug alone is not enough to transform HIV prevention.
“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. Bringing these elements together will be critical to ensuring equitable access and impact,” he added.
The FDA’s tentative approval provides an important regulatory milestone ahead of further steps towards wider availability, including WHO prequalification and national regulatory approvals.
Know more about lenacapavir
Lenacapavir is a first-in-class, long-acting HIV-1 capsid inhibitor with a novel mechanism of action. It targets multiple stages of the HIV lifecycle, distinguishing it from antiviral medicines that act at a single stage of viral replication.
Originally developed by Gilead Sciences, lenacapavir is being investigated for both HIV treatment and prevention, with different formulations and dosing regimens depending on the intended use. The World Health Organization (WHO) recommends twice-yearly lenacapavir in its guidelines for HIV prevention.
The drug is being evaluated in multiple ongoing and planned clinical studies in Gilead’s HIV prevention and treatment research programme, including a once-yearly injection for HIV prevention.
