Osiris Therapeutics, Inc. (OSIR) announced that the European Medicines Agency or EMA has designated Osiris as the Orphan Drug title holder for Prochymal. The EU Commission adopted the decision to transfer the designation of Prochymal as an orphan medicinal product under Regulation (EC) No 141/2000 of the European Parliament and of the Council. The Decision would appear in the EU Community Register of Orphan Medicinal Products.
In Europe, Orphan Drug designation provides a variety of incentives, including market exclusivity for up to 10 years following approval, to companies that develop drugs for underserved patient populations.
In the EU, the Orphan Drug designation for Prochymal is to treat acute graft versus host disease or GvHD. Prochymal, a first-in-class allogeneic stem cell therapy, has already received approval in Canada and New Zealand for the treatment of acute GvHD in children, and is currently available in seven other countries including the United States under an Expanded Access Program.
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