PTC Therapeutics reports update on marketing application for Sephience in Europe

PTC Therapeutics (PTCT) announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has issued a positive opinion on the marketing authorization application for Sephience, or sepiapterin, for the treatment of children and adults living with phenylketonuria, or PKU. The opinion includes a broad label inclusive of all ages and disease severities. Launch planning in Europe is well underway with priorities in Germany and other key European markets where named patient access will be immediately available. PTC expects the European Commission to ratify the marketing authorization for Sephience in approximately two months. The decision will be applicable to all 27 European Union member states, as well as Iceland, Norway and Liechtenstein. The New Drug Application for sepiapterin is under review by the FDA with a Prescription Drug User Fee Act target action date of July 29.