Arrowhead Receives FDA Fast Track Designation for ARO-APOC3
Retrieved on:
Monday, March 20, 2023
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Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ARO-APOC3 for reducing triglycerides in adult patients with familial chylomicronemia syndrome (FCS).
Key Points:
- Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ARO-APOC3 for reducing triglycerides in adult patients with familial chylomicronemia syndrome (FCS).
- ARO-APOC3 was previously granted Orphan Drug designation by the FDA and the European Union.
- Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need.
- This designation makes Arrowhead eligible for multiple potential benefits including more frequent interactions with FDA, eligibility for accelerated approval and priority review, and rolling review of the new drug application (NDA).