Dr. Reddy's & Gilead Pact Ignites Hope for Once-Yearly HIV Prevention Globally

In a major stride for global public health, India's Dr Reddy's Laboratories has forged a crucial royalty-free, non-exclusive voluntary licensing agreement with US-based biotech giant Gilead Sciences for an investigational once-yearly lenacapavir, designed for HIV prevention. Announced today, this landmark pact is poised to dramatically expand future access to cutting-edge Pre-exposure prophylaxis (PrEP) in 120 low- and lower-middle-income countries, including India. This new collaboration builds upon an existing arrangement from October 2024 for twice-yearly lenacapavir, aiming to accelerate manufacturing readiness and technology transfer for the even more convenient annual injection. While the once-yearly formulation is still an investigational drug, currently undergoing Gilead's Phase 3 PURPOSE 365 study, the twice-yearly version has already secured regulatory approval from the US FDA, the European Medicines Agency (EMA), and a recommendation from the World Health Organization (WHO). The move is critical for regions where maintaining regular medication schedules for HIV prevention has been a significant challenge, making longer-acting options key to improving adherence and curbing new infections. Notably, India's Central Drugs Standard Control Organisation (CDSCO) recently recommended waiving local Phase 3 clinical trial and bioequivalence requirements for generic injectable lenacapavir for PrEP, recognizing its urgent public health need. The expanded agreement positions Dr Reddy's as a vital player among a handful of generic manufacturers working with Gilead to ensure widespread availability. This push for long-acting HIV prevention options, especially in high-incidence countries, signifies a global effort to meet ambitious targets for ending the HIV epidemic. As clinical development progresses, the focus will now turn to swift regulatory approval and efficient supply planning, underscoring the pharmaceutical industry's role in addressing major global health crises and improving access to life-saving treatments worldwide.