Raptor Receives Marketing Authorization For PROCYSBI In EU

(RTTNews) - Raptor Pharmaceutical Corp. (RPTP) Thursday said the European Commission has approved PROCYSBI gastro-resistant hard capsules of cysteamine as an orphan medicinal product for the treatment of proven nephropathic cystinosis for marketing in the European Union.

The approval of the marketing authorization application or MAA by the EC follows the positive recommendation by the European Medicines Agency's Committee for Medicinal Products for Human Use in June.

The orphan medicinal product designation provides a 10-year period of market exclusivity in the EU that starts from the notification date of the EC Decision granting the MAA.