EMA Authorised: Sephience (sepiapterin) — PTC Therapeutics International Limited

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Summary

The EMA authorised Sephience (sepiapterin) for phenylketonuria, with orphan medicine status, and PTC Therapeutics International Limited as the marketing authori…

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Diseases / indications

• Phenylketonuria

Drugs mentioned

• SEPHIENCE (SEPIAPTERIN)

Snippet

Status: Authorised. Therapeutic area: Phenylketonurias. MAH: PTC Therapeutics International Limited. Decision date: 28/08/2025. Orphan medicine