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FDA Approves Drug for Myelodyplastic Syndromes

Dacogen promotes normal cell development in about 22 percent of patients

THURSDAY, May 4 (HealthDay News) -- The U.S. Food and Drug Administration has approved Dacogen (decitabine) injection for the treatment of myelodyplastic syndromes (MDS). The drug, which is a new molecular entity, was given orphan status under the Orphan Drug Act, and therefore has a seven-year period of exclusive marketing because it is used to treat a condition that affects fewer than 200,000 people in the United States.

There are an estimated 7,000 to 12,000 new cases of MDS a year in the United States. Symptoms include weakness, fatigue, infections, easy bruising, bleeding and fever, and although it occurs in all age groups it is most common in those over the age of 60. In trials the drug was tested on 268 patients, of which approximately 22 percent had complete or partial responses such as normalization of blood counts.

"Today's approval of Dacogen offers patients with this rare disease an additional treatment option that may help these patients avoid blood transfusions," said Steven Galston, M.D., director of FDA's Center for Drug Evaluation and Research, in a statement.

The drug is manufactured by Pharmachemie B.V. Haarlem in the Netherlands, for MGI Pharma Inc. of Bloomington, Minn.

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