An injectable drug to treat a rare group of diseases of the bone marrow that are often fatal won federal approval Wednesday.
The Food and Drug Administration said Dacogen would provide an additional treatment option for patients suffering from myelodysplastic syndromes. The condition is marked by bone marrow that does not produce enough mature blood cells.
The drug, also known as decitabine, is believed to promote normal development of blood cells. In three clinical trials, about one-fifth of patients treated with Dacogen had a complete or partial response to the drug, the FDA said.
There are different types of myelodysplastic syndromes, which can develop following treatment with drugs or radiation for other diseases. Some forms of the diseases can develop into acute myeloid leukemia, according to the FDA.
The FDA approved Dacogen under the Orphan Drug Act, which encourages drug companies to develop treatments for rare diseases and conditions. An estimated 7,000 to 12,000 new myelodysplastic syndrome cases are diagnosed each year in the United States.
Myelodysplastic syndromes are most common in the elderly. Symptoms include weakness, fatigue, infections, easy bruising, bleeding and fever.
The most common side effects of Dacogen include low white blood cell count, low platelets in blood, anemia, fatigue, fever, nausea, cough, bleeding in the skin, constipation, diarrhea and high blood sugar.
Dacogen is made by Netherlands-based Pharmachemie B.V. Haarlem for MGI Pharma Inc. of Bloomington, Minn.
Other drugs to treat myelodysplastic syndromes include Vidaza and Revlimid.