US FDA grants tentative approval for Dr. Reddy’s twice-yearly injectable lenacapavir 

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to 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 77 pounds (35 kg). The approval was granted under the U.S. FDA’s President’s Emergency Plan for AIDS Relief (PEPFAR) program. The approval builds on the voluntary licence granted by Gilead Sciences to Dr. Reddy’s in October 2024, followed by an agreement with Unitaid, the Wits Reproductive Health and HIV Institute (Wits RHI) and the Clinton Health Access Initiative (CHAI) in September 2025 to support product development, accelerate the regulatory pathway and enable access to injectable lenacapavir at US$40 per person per year across 120 countries in Gilead’s voluntary licence. The FDA approval represents an important milestone for Dr. Reddy’s Public Health Access portfolio and reflects the company’s capabilities in developing and manufacturing complex medicines. The first supplies are expected to reach people by the end of 2026, with broader rollout across eligible countries expected in 2027. HIV continues to pose a significant global public health challenge, with gaps remaining in access to and uptake of effective prevention options. Long-acting lenacapavir, administered twice a year, provides an additional prevention option for people who may face challenges with more frequently administered pre-exposure prophylaxis (PrEP). Deepak Sapra, Chief Executive Officer, API and Services, Dr. Reddy’s Laboratories 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. 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. 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. 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 prioritize access from the start. This should be the new standard for global health.” Professor Saiqa Mullick, Director of Implementation Science at Wits RHI, University of the Witwatersrand said, “Generic lenacapavir has the potential to transform HIV prevention, and this is a significant milestone, but an affordable drug alone is not enough. 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.” FDA approval provides an important regulatory basis for the remaining steps towards wider availability, including WHO prequalification and national regulatory approvals. Unitaid and partners are supporting countries and communities with product introduction and scale-up, including community engagement and real-world evidence generation to inform how lenacapavir can effectively reach diverse and underserved populations.   The post US FDA grants tentative approval for Dr. Reddy’s twice-yearly injectable lenacapavir  appeared first on Express Pharma.