Stories
CDSCO Eases Path for Generic HIV Drug Lenacapavir, Accelerating India Launch
- •Indian drugmakers are closer to launching affordable generic lenacapavir after CDSCO recommended waiving local late-stage clinical trials, removing a major hurdle.
- •Emcure Pharmaceuticals has filed its injectable version with DCGI and hopes for approval by fiscal year-end, with other companies like Dr Reddy's and Hetero also developing generics.
- •Lenacapavir is a long-acting HIV drug, reducing dosing burden, and its generic versions are expected to be significantly more affordable than the original drug in developed countries.
- •The waiver, citing unmet medical need, is a significant step towards faster access to a promising HIV prevention tool, though post-marketing Phase IV studies are recommended.
- •While the waiver applies to prevention, MSF noted the CDSCO panel did not recommend a similar waiver for lenacapavir's treatment indication for multidrug-resistant HIV.
Key Questions Answered
The subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) recommended waiving local Phase III clinical trials and bioequivalence studies for generic lenacapavir due to unmet medical need. This waiver aims to cut development time and costs, though post-marketing Phase IV studies have been recommended.
Public indications from manufacturers like Dr Reddy's and Hetero point to an estimated annual treatment cost of around $40 in India, which covers the twice-yearly injections and accompanying tablets. This is a fraction of the cost in the developed world, where prices can exceed $28,000 to $42,000 annually.
A generic rollout of lenacapavir across licensed low- and middle-income markets is anticipated starting from 2027, according to Médecins Sans Frontières (MSF). Meanwhile, Indian drugmakers like Emcure Pharmaceuticals are aiming for local approvals by the end of the fiscal year.
