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news.The Gamida Cell-Teva joint venture has received the orphan drug designation from European Commission for the investigational medicinal product StemEx for the treatment of acute lymphoblastic leukemia and acute myeloid leukemia.
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The European Commission consequently follows the positive opinion of the European Medicine Agency’s Orphan Medicinal Products Committee. The FDA granted StemEx orphan drug designation in March 2005 for use as hematopoietic support in patients with relapsed or refractory hematologic malignancies who are receiving high dose therapy.
Yael Margolin, CEO of Gamida Cell, said: “This is very important news. Having an orphan drug designation for StemEx in the US and now in Europe affords an impressive array of financial and product development benefits. Today’s news moves StemEx one step closer to market launch.”