Zydus Usnoflast Gets Orphan Drug Designation for ALS Treatment

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Jan 22, 2025 19:32

Zydus Lifesciences's Usnoflast receives Orphan Drug Designation from the USFDA for the treatment of Amyotrophic Lateral Sclerosis (ALS), a rare neurodegenerative disease.
Zydus Usnoflast Gets Orphan Drug Designation for ALS Treatment
Photograph: Courtesy Zydus.
New Delhi, Jan 22 (PTI) Zydus Lifesciences on Wednesday said the US health regulator has granted Orphan Drug Designation to Usnoflast, a product under development for the treatment of amyotrophic lateral sclerosis.

The US Food Drug Administration's Office grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than two lakh people in the US.


"This Orphan Drug Designation from the USFDA underlines the urgent need to develop Usnoflast to address Amyotrophic Lateral Sclerosis (ALS), which is a fatal neurodegenerative disease," Zydus Lifesciences Chairman Pankaj Patel said in a statement.

ALS affects around 32,000 people in the US and on average 5,000 new patients are diagnosed every year with this disease, as per statistics from the Centre for Disease Control and Prevention (CDC).
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