Marrow drug gets FDA OK
Monday, May 24, 2004
Washington -- The government has approved sale of the first drug to treat a bone marrow disease that can lead to leukemia.
Called Vidaza, the injection treats the rare but dangerous myelodysplastic syndrome, or MDS.
MDS is a precancerous condition in which DNA damage inside bone marrow stem cells blocks their function to make blood cells and results in not enough normal blood cells being produced.
Common treatments include blood or platelet transfusions and antibiotics to fight infection.
The new drug is thought to bring some patients into remission by correcting the DNA damage so proper blood-cell production can resume, said Ann Farrell of the Food and Drug Administration.
The FDA approved Vidaza, known chemically as azacitidine, after studies showed it helped blood counts normalize in about 16% of patients, eliminating the need for transfusions.
No one yet knows how long the effect will last, or if patients will need to resume treatment when a remission ends.
Side effects include nausea, diarrhea, fatigue, irritation at the injection site and constipation.
FDA classified Vidaza as an "orphan drug" because MDS affects just 7,000 to 12,000 patients a year, mostly people over age 60.
It may develop following treatment with radiation or other drugs for other diseases, or for no known cause. Symptoms include weakness, fatigue, infections, easy bruising, bleeding and fever.
The drug's maker is Pharmion Corp. of Boulder, Colo.
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