Latest news with #Usnoflast
Business Standard
7 days ago
- Health
- Business Standard
Zydus Lifesciences' Usnoflast receives USFDA fast track designation for ALS Treatment
Zydus Lifesciences announced that the U.S. Food and Drug Administration (USFDA) has granted Fast Track Designation to Usnoflast (ZYIL1), a novel oral NLRP3 inhibitor, for the treatment of Amyotrophic Lateral Sclerosis (ALS). 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, Parkinsons 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.
Business Upturn
7 days ago
- Health
- Business Upturn
Zydus receives USFDA Fast Track Designation for Usnoflast in the treatment of ALS
By Aman Shukla Published on May 28, 2025, 11:14 IST Zydus, a discovery-driven global pharmaceutical company, has announced that the United States Food and Drug Administration (USFDA) has granted Fast Track Designation to its investigational drug, Usnoflast, for the treatment of amyotrophic lateral sclerosis (ALS). This designation is intended to expedite the development and review of drugs that address serious conditions and fill an unmet medical need. It allows for more frequent communication with the FDA and makes the drug eligible for accelerated approval and priority review, provided certain criteria are met. ALS is a progressive neurodegenerative disease that primarily affects motor neurons. Patients with ALS typically experience muscle weakness, loss of motor control, difficulty speaking and swallowing, and ultimately respiratory failure. The average life expectancy following diagnosis ranges from two to five years. Neuroinflammation and axonal degeneration are key features of the disease, contributing to the buildup of neurofilaments in cerebrospinal fluid and, eventually, in the bloodstream. This process is linked to the rapid progression and severe impact of ALS on physical function and quality of life. Usnoflast, also known as ZYIL1, is an oral small molecule that targets the NLRP3 inflammasome pathway, which is believed to play a role in neuroinflammatory diseases. The drug has shown promise in pre-clinical studies involving models of neuroinflammation, Parkinson's disease, Inflammatory Bowel Disease (IBD), and Multiple Sclerosis (MS). In India, Zydus completed a Phase 2(a) randomized, double-blind, placebo-controlled trial of Usnoflast in 24 ALS patients across seven clinical trial sites. The study is registered under the Identifier NCT05981040. Building on this research, Zydus has received USFDA approval to begin a Phase 2(b) clinical trial in the United States. This upcoming study will also be randomized, double-blind, and placebo-controlled, further evaluating the potential of Usnoflast as a treatment option for ALS. ALS affects an estimated 32,000 individuals in the U.S., with approximately 5,000 new cases diagnosed each year. In Europe, more than 30,000 people are believed to be living with the condition, and in India, the number is estimated to be around 75,000. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
