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. “Orphan drug designation would expedite our development of a therapy that we believe could bring relief to children and teenagers suffering from active ulcerative colitis,” Chris Prior, PhD, Innovate’s CEO, said in a press release. “There is an unmet need for an effective treatment for this disease and INN-108 is a promising potential therapy. Our FDA submission is a major milestone toward making this therapy available,” Prior added. Ulcerative colitis is an inflammatory bowel dis
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