Raptor Pharma: Cysteamine Bitartrate Gets Orphan Drug Designation In EU

(RTTNews) - Raptor Pharmaceutical Corp. (RPTP) announced that the European Commission (EC) 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 of the Agency in June.

"This designation is an important milestone as Raptor moves through the regulatory process for the potential approval of RP103 as a treatment for Huntington's disease in the EU," said Christopher Starr, Raptor's CEO.

Orphan designation provides Raptor Pharma with 10 years of marketing exclusivity in the EU after the Marketing Authorisation Application approval.