Posted by Michael Wonder on 23 Apr 2024
Medicure receives US FDA fast track designation for MC-1 for PNPO deficiency
23 April 2024 - Medicure announced today that through its subsidiary, Medicure International, the US FDA has granted fast track designation for MC-1, an investigational product for the prevention or treatment of seizures associated with pyridox(am)ine 5'-phosphate oxidase (PNPO) deficiency.
Medicure is in the launch phase of its Phase 3 clinical trial to treat approximately 10 PNPO deficient patients at sites in the US and Australia with daily doses of MC-1.
