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EMA recommends Catalyst's hemophilia B drug for orphan designation

The European Medicines Agency's Committee for Orphan Medicinal Products issued a positive opinion recommending orphan medicinal product designation for Catalyst Biosciences Inc.'s CB 2679d/ISU304 to treat hemophilia B.

Deficiency of a protein known as Factor IX causes hemophilia B. Catalyst's drug has demonstrated, in preclinical studies, the potential to normalize human Factor IX levels with a daily subcutaneous injection.

Catalyst Biosciences' South Korean collaborator, ISU Abxis, plans to initiate a phase 1/2 proof-of-concept study of the drug in individuals with severe hemophilia B in June 2017 in South Korea.