US FDA Granted Fast Track Designation to Medicure’s MC-1 for PNPO deficiency
Shots:
- US FDA granted Fast Track designation to Medicure’s MC-1 for seizures associated with PNPO deficiency. Also received Rare Pediatric Disease Designation and ODD by US FDA; ODD by EMA
- Medicure is in launch phase of P-III study, daily dose of MC-1 will be administered to approx. 10 PNPO patients in US and Australia
- If FDA approves NDA for MC-1, Medicure will receive Priority Review voucher which can be redeemed or sold
Ref: Medicure | Image: Medicure
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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.
