PTC Therapeutics (PTCT) said Friday that its marketing authorization application for Sephience for the treatment of phenylketonuria has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use.
The CHMP opinion recommends a label that includes all ages and disease severities, the company said, adding it expects the European Commission to take a decision in about two months.
The company said launch planning in Europe is ongoing, with Germany as a priority market.
Sephience, or sepiapterin, is also under review in the US for phenylketonuria, an inherited metabolic disease that affects the brain, PTC said.
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