Dacogen(TM) (Decitabine) for Injection Receives U.S. Orphan Drug Designation for Patients with AML Thursday August 10, 7:01 am ET
MINNEAPOLIS--(BUSINESS WIRE)--Aug. 10, 2006--MGI PHARMA, INC. (Nasdaq:MOGN - News), a biopharmaceutical company focused in oncology and acute care, today announced that the United States Food and Drug Administration (FDA) has granted Dacogen(TM) (decitabine) for Injection orphan designation for the indication of acute myeloid leukemia (AML). Dacogen was approved by the FDA on May 2, 2006 for the treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British (FAB) 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 (IPSS) groups.
Orphan drug designation was designed to promote the development of products that demonstrate promise for the diagnosis and/or 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 previously designated as an orphan drug in the U.S. for the MDS indication.
Dacogen is being co-developed by MGI PHARMA 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 PHARMA retains responsibility for all activities in the United States, Canada and Mexico.