MGI PHARMA'S CANCER DRUG GRANTED ORPHAN STATUS IN EUROPE

The European Medicines Agency has granted MGI Pharma's leukemia drug Dacogen orphan drug status. The classification gives the company incentives to further develop the drug, such as tax breaks and a 10-year marketing exclusivity status following approval.

Dacogen is aimed at treating acute myeloid leukemia, the most common form of leukemia in adults. The drug is already approved in the United States for myelodysplastic syndromes (MDS), which includes a variety of bone marrow disorders. It already has orphan status in Europe for MDS.

The drug is being codeveloped by Janssen-Cilag, a Johnson & Johnson subsidiary that handles regulatory and commercial activities outside of North America.