The Aplastic Anemia & MDS International Foundation is pleased to inform patients that the European Committee for Medicinal Products for Human Use (CHMP) has awarded Vidaza (azacitidine) a positive opinion for the treatment of myelodysplastic syndromes (MDS) patients who are not eligible for stem cell transplants.
The CHMP's positive opinion is based on data from the AZA-001 trial, which demonstrated an overall, unprecedented survival benefit for higher-risk MDS patients. The positive opinion will be forwarded to the European Commission that generally follows the recommendation of the CHMP and issues final marketing approval.
"We are excited by Vidaza's positive CHMP opinion because there are few treatment options for patients in Europe with this disease," said John Huber, Executive Director of the Aplastic Anemia & MDS International Foundation, "Vidaza not only extends patients' lives, but also improves their quality of life. We are hopeful that Vidaza will receive marketing approval shortly and quickly be available for patients across Europe."
Myelodysplastic syndromes (MDS) occur when the bone marrow stem cells malfunction. This results in the production of too many defective blood cells and not enough normal cells. Diagnosis is made through blood tests and a bone marrow biopsy. Once diagnosed, treatment and evaluation should occur under the care of a hematologist or hematologists/oncologist. There are many subtypes of MDS classified according to how the disease manifests itself in the blood and marrow of the patient. Treatments include blood transfusions, growth factors, chemotherapy and bone marrow transplant.
|Contact: John Huber|
Aplastic Anemia & MDS International Foundation