Applied Therapeutics Reports the US FDA’s Acceptance of NDA with Priority Review for Govorestat to Treat Classic Galactosemia
Shots:
- The US FDA has accepted and granted priority review to the NDA for govorestat (AT-007) to treat classic galactosemia, with the decision expected on Aug 28, 2024
- The NDA was based on multiple studies incl. a P-III (ACTION-Galactosemia Kids) trial in galactosemia patients (2-17yrs. of age), P-I/II (ACTION-Galactosemia) trial in adults with galactosemia plus preclinical results. Govorestat in the studies showed quick & sustained galactitol reduction, leading to clinical benefits in pediatric patients
- Govorestat, an aldose reductase inhibitor (ARI), is currently being assessed in the P-III (INSPIRE) study for its efficacy vs PBO in SORD deficiency patients (n=~50, 16-55yrs. of age) in the US & the EU
Ref: Applied Therapeutics | Image: Applied Therapeutics
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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.
