Generic Twice-Yearly HIV PrEP Gets FDA Tentative Approval for Global Access
The FDA has granted tentative approval to Dr. Reddy’s generic version of lenacapavir for HIV pre-exposure prophylaxis, paving the way for affordable access in 120 low- and middle-income countries at just $40 annually. The drug, which requires only two doses per year, demonstrated 100% efficacy in one trial and 89% in another, outperforming daily oral regimens. Experts emphasize that affordability must be paired with strong health system infrastructure to ensure effective rollout.
The U.S. Food and Drug Administration (FDA) has granted tentative approval to Dr. Reddy’s Laboratories for a generic version of lenacapavir, a long-acting injectable drug used for pre-exposure prophylaxis (PrEP) against HIV. This marks the first time a generic formulation of lenacapavir has received such approval, specifically intended for use in 120 low- and middle-income countries. The drug is designed to be administered just twice yearly—once every six months—and is projected to cost approximately $40 per person annually, significantly lowering access barriers compared to the branded version. This approval followed 16 months after Gilead Sciences’ original lenacapavir was approved for PrEP in the U.S., and first generic doses are expected to reach target countries by the end of 2026. Clinical trial data from PURPOSE 1 showed a 100% reduction in HIV risk among participants, while PURPOSE 2 reported an 89% reduction compared to daily oral regimens like FTC/TDF.
The development builds on prior efforts to expand access to HIV prevention tools, particularly in regions where adherence to daily pills remains a challenge. Gilead’s original drug was approved based on strong efficacy data, but its high cost limited widespread use in resource-limited settings. Dr. Reddy’s entry into the market represents a strategic move by generic manufacturers to increase affordability and availability. The company aims to support global health equity by enabling broader distribution, while public
This development could significantly shift HIV prevention dynamics in low- and middle-income countries where adherence to daily oral PrEP remains a persistent challenge. By reducing dosing frequency from daily to twice-yearly injections, lenacapavir may improve long-term compliance and reduce transmission rates, particularly among populations with limited access to consistent medical care. The $40 annual cost could make it feasible for national programs to scale up prevention efforts without overwhelming budgets. However, the real-world impact will depend on whether health systems can adapt to deliver injectable therapies reliably—something that may strain already overburdened clinics in rural or conflict-affected regions. A comparable precedent is the rollout of long-acting injectable antiretrovirals for HIV treatment, which faced similar infrastructure hurdles despite lower dosing frequency. The success of lenacapavir PrEP could influence pharmaceutical pricing models and encourage