Drug major Dr Reddy’s Laboratories Ltd on Monday (November 2) said the US Food and Drug Administration (USFDA) has granted tentative approval to its twice-yearly injectable lenacapavir for HIV prevention, paving the way for access across 120 countries outside the US under an existing voluntary licensing agreement.
The approval covers the use of 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). It was granted under the USFDA’s President’s Emergency Plan for AIDS Relief (PEPFAR) programme.
Under the existing agreement, the injectable drug will be available at $40 per person per year across 120 countries covered by Gilead Sciences’ voluntary licence. Gilead granted the licence to Dr Reddy’s in October 2024.
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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 treatment.
The organisations supported the accelerated development and regulatory pathway for the twice-yearly injection. The first supplies are expected to reach countries before the end of 2026, with broader availability across eligible countries in 2027.
Deepak Sapra, Chief Executive Officer, API and Services, Dr Reddy’s Laboratories Ltd, said, “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.
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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. We are grateful to Gilead for the voluntary licence and to Unitaid, Wits RHI and CHAI for their support in accelerating this journey.”
Dr Philppe Duneton, Executive Director at Unitaid, said, “Unitaid’s early risk-taking is helping shorten the time between a scientific breakthrough and real access in countries. With best-in-class HIV treatment, we delivered in four years what used to take ten.
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, with the potential to avert countless infections and drive meaningful change in the HIV response.”
Dr Neil Buddy Shah, CEO of CHAI, said, “For someone at risk of HIV, taking a pill every day to prevent a disease they don’t have is a hard thing to ask. Two injections a year of a product that is almost 100% effective at preventing HIV changes that entirely.
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More than 125,000 people in Africa have already started on lenacapavir, and today’s approval brings us closer to making it available to millions more for just $40 a 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.”
Shares of Dr Reddy’s Laboratories Ltd ended at ₹1,340.25, down by ₹9.95, or 0.74%, on the BSE.