Mitsubishi Tanabe Pharma America Receives U.S. Food and Drug Administration Orphan Drug Exclusivity for RADICAVA ORS® (edaravone)
Retrieved on:
Monday, April 8, 2024
MTPA, Orphan drug, ALS, RWE, ODE, Patient, ALS Association, Edaravone, Safety, HCP, FDA, Health, Food, Pharmaceutical industry
JERSEY CITY, N.J., April 8, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that the U.S. Food and Drug Administration (FDA) has recognized seven years of Orphan Drug Exclusivity (ODE) for RADICAVA ORS® (edaravone) based on their assessment that the oral form of edaravone constitutes a major contribution to patient care for people living with amyotrophic lateral sclerosis (ALS). The FDA's Orphan Drug program is designed to support the development of drugs that treat rare diseases which affect less than 200,000 people in the U.S. Previously, the FDA granted RADICAVA ORS Priority Review and Fast Track designations.
Key Points:
- The FDA's Orphan Drug program is designed to support the development of drugs that treat rare diseases which affect less than 200,000 people in the U.S.
- Previously, the FDA granted RADICAVA ORS Priority Review and Fast Track designations.
- The FDA recognized ODE for RADICAVA ORS because it provides a clinically superior option for patients due to its oral suspension route of administration that can help reduce the burden patients face with intravenous (IV) administration of previously approved RADICAVA® (edaravone).
- "We thank Mitsubishi Tanabe Pharma America for continuing their efforts to help provide treatments to people living with ALS."