Aplastic Anemia & MDS International Foundation
FDA Approves Vidaza Label Expansion
Published in Medical Letter on the CDC and FDA, September 7th, 2008
The Aplastic Anemia & MDS International Foundation (AA&MDSIF) is pleased to inform patients that the U.S. Food & Drug Administration (FDA) has expanded the label for VIDAZA (azacitidine) to include data from the AZA-001 trial, which found that Vidaza is the only agent that extends survival in MDS (myelodysplastic syndromes) patients. Vidaza was also shown to delay progression to acute myelogenous leukemia (AML) in patients with MDS. Roughly 30 percent of patients diagnosed with MDS will progress to AML.
"We are very encouraged by the Vidaza data from the AZA-001 trial. This trial showed, for the first time, a drug can extend survival for MDS patients," said John Huber,...
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