Overview
- An expert Subject Expert Committee under India’s drug regulator recommended waiving local Phase III and bioequivalence trials for Dr Reddy’s and Emcure’s lenacapavir PrEP applications, a measure the panel recorded on 11 August 2026 to shorten the regulatory pathway.
- The panel made the waiver conditional on companies submitting Phase IV study protocols to CDSCO within three months and on enforcing confirmed HIV-negative testing before starting the twice-yearly injectable.
- The recommendation applies only to lenacapavir for pre-exposure prophylaxis and does not lift local trial requirements for the drug’s treatment use in people with multidrug-resistant, heavily treatment-experienced HIV.
- Global PURPOSE Phase III trials showed very high prevention efficacy for twice-yearly lenacapavir, including zero infections in one cohort and a 96% incidence reduction in another, and clinicians say the six-month dosing could improve adherence versus daily oral PrEP.
- Major questions remain about final marketing approvals, pricing, inclusion in public HIV programmes, and the systems needed to deliver injections and repeat HIV testing even if low-cost generics backed by Gilead licences become available.