Shots:
- The EC has approved Sephience (sepiapterin) to treat PKU in pts of all ages and disease severities across all 30 EEA states; launch is anticipated in Germany in H1 of July
- Approval was based on APHENITY study results and long-term extension data showing durable effects and improved dietary flexibility
- Sephience is an oral synthetic sepiapterin with a dual mechanism that boosts phenylalanine hydroxylase (PAH) enzyme activity. Sepiapterin’s NDA is under FDA review (PDUFA: July 29, 2025), and approval reviews are underway in countries like Japan and Brazil
Ref: PRNewswire | Image: PTC Therapeutics| Press Release
Related News:- Sandoz Reports EC’s Approval of Wyost and Jubbonti (Biosimilars, Xgeva and Prolia)
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