FDA gives Dacogen orphan drug status

MGI Pharma announced that the FDA had given orphan drug status to Dacogen as a therapy for leukemia. Dacogen is currently in late-stage trials for leukemia and was approved for bone marrow disorders in May. European regulators have given Dacogen orphan drug status for Myelodysplastic Syndromes and leukemia. Orphan drug status provides seven years of market exclusivity for a drug aimed at a small group of patients.

- read the AP report [1] on Dacogen