Shots:
- The CHMP has issued a positive opinion recommending marketing authorization for Sephience (sepiapterin) to treat PKU in patients of all ages and disease severities, expected the EC approval within two mos., with the decision applying across the EU including Iceland, Norway, and Liechtenstein
- Sepiapterin’s NDA is under FDA review (PDUFA: July 29, 2025), and approval reviews are underway in countries like Japan and Brazil
- Sephience is an oral synthetic sepiapterin with a dual mechanism that boosts phenylalanine hydroxylase (PAH) enzyme activity
Ref: Prnewswire| Image: PTC Therapeutics | Press Release
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