Applied Therapeutics Receives Complete Response Letter for Govorestat’s NDA for Treating Classic Galactosemia
Shots:
- The US FDA has issued a CRL for govorestat's NDA to treat classic galactosemia, stating deficiencies in the application. The company plans to review the feedback & request a meeting to discuss resubmission or appeal
- The registrational P-III (ACTION-Galactosemia Kids) trial showed improved daily activities, behavioral symptoms, cognition, fine motor skills & tremor in children (2-17yrs.), with reduced plasma galactitol in both children & adults; another supporting trial confirmed its safety & efficacy in 185 subjects over 3yrs.
- Govorestat is also being studied for Sorbitol Dehydrogenase (SORD) Deficiency, with its NDA planned in Q1’25. CRL doesnot affects this submission
Ref: Applied Therapeutics | Image: Applied Therapeutics
Related News:- Applied Therapeutics Reports the US FDA’s Acceptance of NDA with Priority Review for Govorestat to Treat Classic Galactosemia
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
