Zydus Lifesciences' ALS Drug Usnoflast Gets US FDA Fast Track Status

Zydus Lifesciences Ltd. on Wednesday said the US Food and Drug Administration has granted 'Fast Track Designation' to its oral small molecule NLRP3 inhibitor, Usnoflast. The designation makes the drug eligible for accelerated approval and priority review if key conditions are met, the company said in an exchange filing.

Usnoflast had earlier received 'Orphan Drug Designation' from the US FDA. Zydus said it remains committed to advancing neuroscience research and is developing Usnoflast for patients with amyotrophic lateral sclerosis (ALS).

The company recently secured approval from the US FDA to begin a randomised, double-blind, placebo-controlled Phase 2 clinical trial of Usnoflast in ALS patients.