EU orphan designation for Osiris' Prochymal
US firm Osiris Therapeutics has received Orphan Drug designation from the European Medicines Agency (EMEA) for prochymal, an adult stem cell product in Phase III pivotal trials for the treatment of acute graft-versus-host disease.
Prochymal has already been granted both Orphan Drug and Fast-Track status by the US Food and Drug Administration, expediting the development of the stem cell treatment for acute GVHD.
The ongoing Phase III study of the agent in this indication is anticipated to be the final trial before the product is submitted to the FDA, as well as Canadian and European regulatory agencies for full approval, the company noted.
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