PTC Therapeutics Inc. has received Health Canada approval for Sephience™ (sepiapterin) for the treatment of children and adults with phenylketonuria (PKU). The approval covers all age groups and all PKU subtypes, allowing treatment of patients one month old and older with sepiapterin-responsive PKU. The decision was based on significant efficacy and safety results from the Phase 3 APHENITY trial and its long-term extension study. Sephience is now commercially available in Canada, following recent approvals in the U.S. and Europe.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. PTC Therapeutics Inc. published the original content used to generate this news brief via CNW (Ref. ID: C6703) on December 10, 2025, and is solely responsible for the information contained therein.
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