Agios Pharmaceuticals (AGIO) announced that the European Commission, EC, has adopted a positive decision for the designation of mitapivat, an oral, small molecule PK activator, as an orphan medicinal product, OMP, for the treatment of sickle cell disease. Earlier, in November 2020, the U.S. Food and Drug Administration, FDA, also granted orphan drug designation to mitapivat for sickle cell disease.
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