Now Reading: CDSCO panel waives Phase 3 trials for generic HIV prevention drug lenacapavir
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CDSCO panel waives Phase 3 trials for generic HIV prevention drug lenacapavir
CDSCO panel waives Phase 3 trials for generic HIV prevention drug lenacapavir
An expert panel under India's drug regulator has recommended waiving local Phase 3 clinical trials for generic versions of lenacapavir, a twice-yearly injectable drug for HIV prevention. The Subject Expert Committee on…
An expert panel under India's drug regulator has recommended waiving local Phase 3 clinical trials for generic versions of lenacapavir, a twice-yearly injectable drug for HIV prevention. The Subject Expert Committee on Antimicrobial & Antiparasitic Drugs under the CDSCO made the recommendation for applications from Dr Reddy's Laboratories and Emcure Pharmaceuticals at its 11 August meeting.
Lenacapavir, developed by US-based Gilead Sciences, is approved in the US as Yeztugo for HIV pre-exposure prophylaxis (PrEP). Gilead has voluntary licensing agreements with six generic manufacturers, including Dr Reddy's and Emcure, to supply the drug in 120 low- and middle-income countries. The waiver does not amount to final marketing approval, but could substantially shorten the time needed to bring the drug to the Indian market.
Once marketing authorisation is granted, both companies must submit Phase IV study protocols to CDSCO within three months. The committee also specified that individuals must test negative for HIV-1 before starting lenacapavir.
Indian Opinion Analysis
The waiver addresses a long-standing access gap: Indian manufacturers have been licensed to supply lenacapavir to other countries but could not sell it domestically without repeating trials already conducted globally. Oral PrEP, the existing option, requires daily dosing that many find hard to sustain due to stigma or privacy concerns. The CDSCO's Phase IV requirement means post-marketing safety data will come from real-world use in India rather than delaying access by years. The next step to watch is the final marketing authorisation decision by the Drugs Controller General of India, which will determine when the generic can actually be prescribed.
Source: theprint.in
This story was synthesised by AI from the source linked above.
