EU approval for Raptor's Procysbi

US drugmaker Raptor Pharmaceutical (Nasdaq: RPTP) says that the European Commission has approved its Procysbi gastro-resistant hard capsules of cysteamine (as mercaptamine bitartrate) as an orphan medicinal product for the treatment of proven nephropathic cystinosis, a rare genetic condition, for marketing in the European Union.

The approval of the drug by the EC follows the positive recommendation by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in June 2013. 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.

The drug has also been cleared for the same indication in the USA (The Pharma Letter May 1), where a year’s treatment costs around $250,000, according to a report by the San Francisco Business Times.