India drug panel waives local trials for generic HIV prevention shot

India's drug regulator has moved toward allowing generic lenacapavir, a twice-yearly injectable HIV prevention drug, by recommending waiver of local Phase 3 clinical trials for Dr Reddy's Laboratories and Emcure Pharmaceuticals. The expert committee under CDSCO, at its August 11 meeting, cited an unmet medical need and recommended waiving both bioequivalence and Phase 3 trial requirements for the pre-exposure prophylaxis (PrEP) injection.

Lenacapavir, developed by US firm Gilead Sciences, has shown 100% efficacy in a pivotal trial among women and 96% reduction in HIV incidence in a second trial. Generic versions are already licensed for 120 low- and middle-income countries. The recommendation does not grant marketing approval yet, the companies must submit Phase 4 study protocols within three months after receiving authorization.

HIV infections in India rose from 57,549 in 2020 to 68,451 in 2023 before declining to 64,470 in 2024, according to recent data. Activists had urged the regulator to expedite approval and set a target price of $40 per person per year. The waiver could shorten the regulatory pathway that might otherwise have taken 18-24 months more, experts say.