EMEA orphan status for MGI's Dacogen

MGI Pharma, a US biopharmaceutical company focused in oncology and acute care, says that the European Medicines Agency (EMEA) has granted Dacogen (decitabine) for injection orphan designation for the indication of acute myeloid leukemia.

Dacogen was approved by the US Food and Drug Administration on May 2, for the treatment of patients with myelodysplastic syndromes, including previously-treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation and chronic myelomonocytic leukemia), and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System groups.

Dacogen is being co-developed by MGI and Janssen-Cilag, a Johnson & Johnson company. Janssen-Cilag companies are responsible for regulatory and commercial activities in all territories outside North America, while MGI retains responsibility for all activities in the USA, Canada and Mexico.