Raptor Receives Orphan Drug Designation for Cysteamine Bitartrate in Huntington's Disease From the European Commission
Orphan Designation Provides 10 Years of EU Market Exclusivity Upon Approval
NOVATO, Calif., Aug. 4, 2014 -- Raptor Pharmaceutical Corp. (RPTP) today announced that the European Commission (EC) approved its application for orphan drug designation of cysteamine bitartrate, the active ingredient in RP103, for the treatment of Huntington's disease. The decision follows a positive recommendation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) in June. In February of this year, Raptor announced encouraging top line results from a planned 18-month analysis of the blinded, randomized, placebo-controlled phase of its ongoing CYST-HD clinical trial of RP103, its proprietary delayed release cysteamine bitartrate capsule, in patients with early-stage Huntington's disease.
- Published: 05 August 2014
- Written by Editor