EU orphan status for Raptor's cysteamine bitartrate in Huntington's disease
US drugmaker Raptor Pharmaceutical (Nasdaq: RPTP) says that the European Commission has 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 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.
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