MGI'S DACOGEN GRANTED ORPHAN DRUG STATUS FOR LEUKEMIA
MGI Pharma announced that the FDA has granted Dacogen (decitabine) for injection orphan designation for the indication of acute myeloid leukemia. Dacogen was approved in May for the treatment of patients with myelodysplastic syndrome (MDS), including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes.
Orphan drug designation is for products that demonstrate promise for the treatment of rare diseases or conditions that affect fewer than 200,000 people per year in the U.S. and may provide seven years of market exclusivity following FDA approval. Dacogen was also designated an orphan drug in the U.S. for the MDS indication.