Monday 25 August 2008

FDA Approves Vidaza Label Expansion

�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 too shown to delay advance to acuate myelogenous leukemia (AML) in patients with MDS. Roughly 30 per centum of patients diagnosed with MDS will progress to AML.



"We ar very bucked up by the Vidaza data from the AZA-001 trial. This trial showed, for the first time, a drug can extend survival for MDS patients," aforesaid John Huber, Executive Director of the Aplastic Anemia and MDS International Foundation. "We ar excited to see that in this trial Vidaza also decreased the need for blood transfusions."



MDS occur when the bone vegetable marrow stem cells malfunction. This results in the production of overly many defective blood cells and non enough normal cells. Diagnosis is made through blood tests and a bone marrow biopsy. Once diagnosed, treatment and evaluation should occur below the tending of a hematologist or hematologist/oncologist. There are many subtypes of MDS classified according to how the disease manifests itself in the stemma and bone marrow of the patient. Treatments include rip transfusions, growth factors, chemotherapy and bone marrow transplant.






About the Aplastic Anemia and MDS International Foundation




Founded in 1983, the Aplastic Anemia & MDS International Foundation is consecrate to service of process as a resource for patient assist, advocacy, and support. AA&MDSIF provides patients and their families with support, as well as the a la mode medical information. AA&MDSIF as well funds research to receive cures for aplastic genus Anemia, myelodysplastic syndromes (MDS), paroxysmal nocturnal hemogloburina (PNH), and other os marrow loser diseases. Educational and support resources are free to patients and families, the media and the general public at http://www.aamds.org/.



Source: John Huber
Aplastic Anemia & MDS International Foundation




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