India regulator recommends waivers for twice yearly lenacapavir injection trials
Big news for HIV prevention in India: The drug regulator just recommended waivers for local phase III and bioequivalence trials for lenacapavir, a twice-yearly injection designed to help stop HIV.
Dr. Reddy's Laboratories and Emcure Pharmaceuticals got the go-ahead because there was an unmet medical need in India.
Instead of lengthy trials, they'll submit the phase IV post-marketing study protocol in India to CDSCO within three months of receiving marketing authorisation, with efficacy as the primary endpoint.
Gilead Sciences licensed Indian generics makers
The approval was based on strong global data showing lenacapavir works well for adults and adolescents weighing at least 35kg who are at increased risk of sexually acquired HIV.
While it's not cleared yet for multidrug-resistant cases in India (due to limited local data), advocacy groups pushed hard to speed up access.
Gilead Sciences had already licensed Indian companies to make generics, so these drug makers are now licensed to manufacture their generic versions and market them locally and in 120 low- and middle-income countries, and it's approved in the US UK and Australia too.