The fast track designation is designed to facilitate the development and expedite the review of drugs that treat serious conditions and address unmet medical needs. Drugs granted this designation are eligible for benefits such as accelerated approval, priority review, and more frequent interactions with the USFDA during the drug development process.
The company stated that people living with ALS have an average survival of approximately two to five years from diagnosis, with most ALS patients dying from respiratory failure. ALS patients experience neuroinflammation and rapid neurodegeneration. Axonal neurodegeneration leads to the formation of neurofilaments, which first accumulate in the cerebrospinal fluid (CSF) of ALS patients and then slowly enter the bloodstream. Due to rapid neurodegeneration, steady loss of the ability to move, speak, eat, and eventually breathe, paralysis and death are common outcomes in ALS patients. ALS affects approximately 32,000 people in the U.S., with an average of 5,000 new patients diagnosed every year, according to statistics from the Centers for Disease Control and Prevention (CDC). More than 30,000 people are estimated to be living with ALS in Europe (European Union and United Kingdom), while India has an estimated 75,000 people living with ALS.
Usnoflast, a novel chemical entity (NCE), had earlier received Orphan Drug Designation (ODD) from the USFDA, which offers development incentives including tax credits for clinical testing, waiver of certain FDA fees, and a potential seven-year marketing exclusivity upon USFDA approval.
Usnoflast (ZYIL1) is a novel oral small molecule NLRP3 inhibitor studied in preclinical models of neuroinflammation, Parkinson’s disease, inflammatory bowel disease (IBD), and multiple sclerosis (MS). Zydus has completed a Phase 2(a) randomized, double-blind, placebo-controlled trial in 24 ALS patients across seven sites in India and recently received USFDA approval to initiate a Phase 2(b) randomized, double-blind, placebo-controlled trial in ALS patients.
Chairman of Zydus Lifesciences Limited, Pankaj Patel, said, “This ‘Fast Track Designation’ in addition to the previous ‘Orphan Drug Designation’ granted by the USFDA, underlines the urgent need to develop treatments to address Amyotrophic Lateral Sclerosis (ALS), which is a fatal neurodegenerative disease. Zydus is committed to unlocking new frontiers in neuroscience and develop Usnoflast for patients with ALS.”
Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
The company reported a 29.62% jump in consolidated net profit of Rs 1,023.5 crore in Q3 FY25 compared with Rs 789.6 crore in Q3 FY24. Revenue from operations increased 16.96% YoY to Rs 5,269.1 crore during the quarter.
The counter shed 0.30% to Rs 915.22 on the BSE.