India, June 23 -- PTC Therapeutics, Inc. (PTCT) Monday said that the European Commission has granted marketing authorization for Sephience for the treatment of phenylketonuria (PKU).
The company noted that the uthorization includes a broad label inclusive of all ages and disease severities.
The approval is based on results from the Phase 3 APHENITY study as well as evidence of durable treatment effect and the ability of study participants to liberalize their diet in the APHENITY long-term extension study.
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The European launch of Sephience will be initiated in Germany in the first half of July.
The company has submitted a new drug application (NDA) for S...