Innovate Seeks Orphan Drug Status for Pediatric Ulcerative Colitis Therapy Candidate INN-108

Innovate Seeks Orphan Drug Status for Pediatric Ulcerative Colitis Therapy Candidate INN-108
Innovate Biopharmaceuticals recently submitted an application to the U.S. Food and Drug Administration (FDA) seeking orphan drug designation for its potential pediatric ulcerative colitis therapy, INN-108. The FDA issues orphan drug designation to promising treatments for rare diseases affecting fewer than 200,000 people per year in the U.S. The FDA offers incentives including tax credits for clinical testing, seven years of market exclusivity, fast-tracking for regulatory proceedings, and exemption from prescription drug user fees.
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