FDAnews Drug Daily Bulletin

FDA APPROVES MDS MEDICATION

May 12, 2006
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The FDA has approved a new drug from MGI Pharma and SuperGen to treat myelodysplastic syndromes (MDS), a rare bone marrow condition.

Dacogen (decitabine) was granted orphan status, as MDS is diagnosed in an estimated 7,000 to 12,000 people in the U.S. each year. The bone marrow in MDS patients does not produce enough mature blood cells, which can cause anemia, bleeding, infection, fatigue and weakness. Over time, MDS can lead to acute leukemia. High-risk MDS can result in death from bone marrow failure.

Some patients develop MDS after receiving radiation and drug treatments for other diseases while others have no known cause. People over the age of 60 are at the highest risk.

According to announcements by both MGI Pharma and the FDA, nearly 22 percent of patients receiving Dacogen had either complete or partial responses to it and no longer needed transfusions.