Project ALS' Prosetin Receives the US FDA's Orphan Drug Designation for Amyotrophic Lateral Sclerosis
Shots:
- The US FDA has granted ODD to Prosetin for the treatment of ALS. ODD provides incentives for the development of drugs- biologics- and devices for diseases affecting 200-000 or fewer Americans
- By obtaining ODD- Prosetin is now eligible for benefits including up to 7yrs. of marketing exclusivity if it receives regulatory approval- exemption from FDA user fees- FDA assistance in clinical trial design- and tax credits for clinical research
- Prosetin is an oral- brain penetrant MAP4 kinase inhibitor- developed at Columbia University for the treatment of ALS
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