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May 5, 2006 - The FDA has approved a new drug to treat a rare group of bone marrow diseases known as myelodysplastic syndromes.
Officials say the injectable drug Dacogen will provide an additional option for those who are affected by the bone marrow diseases.
An estimated 7,000 to 12,000 people, primarily the elderly, are diagnosed with myelodysplastic syndromes each year in the U.S. The condition occurs when bone marrow does not produce enough mature, healthy blood cells.
Some types of the bone marrow disorder can develop in response to treatment with drugs or radiation designed to treat other diseases. Symptoms of myelodysplastic syndromes include weakness, fatiguefatigue, infections, easy bruising, bleeding, and fever.
Orphan Drug Act
The FDA approved Dacogen this week under the Orphan Drug Act, which encourages drug companies to develop treatments for rare diseases and conditions
.The approval was based on the results of three clinical trials that showed about one-fifth of those treated with Dacogen had a complete or partial response to the drug.
The most common side effects of Dacogen included low white blood cell count, low platelets in blood, low iron in the blood, fever, nausea, cough, bleeding in the skin, constipationconstipation, diarrheadiarrhea, and high blood sugar.
Dacogen is manufactured by Pharmachemie B. V. in Haarlem, Netherlands for MGI Pharma Inc. in Bloomington, Minn.
SOURCE: FDA.