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PTC’s FA Drug Vatiquinone Gets FDA Priority Review

The vatiquinone New Drug Application is based on data from the placebo-controlled MOVE-FA study.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has accepted for filing PTC Therapeutics’ New Drug Application (NDA) for vatiquinone for the treatment of children and adults living with Friedreich’s ataxia (FA). The application has been granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of Aug. 19, 2025. “We are excited to be one step closer to bringing an approved therapy to all patients with Friedreich’s ataxia,” said Matthew...

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