New Treatment for Bone-Marrow Disorders

WEDNESDAY, May 3 (HealthDay News) -- An injectable drug to treat a group of rare bone-marrow disorders called myelodysplastic syndromes (MDS) has been approved by the U.S. Food and Drug Administration.

Dacogen (decitabine) was sanctioned to treat the estimated 7,000 to 12,000 cases of MDS diagnosed each year in the United States, the agency said in a statement. People with MDS have bone marrow that doesn't produce enough red blood cells, leading in some cases to frequent blood transfusions or possible progression to acute myeloid leukemia, a form of blood cancer.

MDS most often strikes people older than 60, although it can affect any age group. Symptoms typically include weakness, fatigue, infections, easy bruising, and fever.

Dacogen, made by Minnesota-based MGI Pharma Inc. and the Dutch firm Pharmachemie B.V. Haarlem, has possible side effects, including low white blood cell count, anemia, fatigue, fever, nausea, and cough, the FDA said.

The medication was approved as an "orphan drug," the agency's designation for conditions that affect fewer than 200,000 people in the United States. It grants the sponsors a seven-year period of exclusive marketing rights.