The MDS Foundation Supports Vidaza's Recommendation For European Approval

Main Category: Blood / Hematology
Also Included In: Lymphoma / Leukemia;  Regulatory Affairs / Drug Approvals
Article Date: 28 Oct 2008 - 6:00 PDT

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The Myelodysplastic Syndromes (MDS) Foundation supports the positive opinion from the European Union's Committee for Medicinal Products for Human Use (CHMP) recommending approval of VIDAZA (azacitidine) for specific types of MDS patients, including those with high-risk MDS, chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia (AML).

The CHMP positive opinion was based upon data from the AZA-001 trial, which found that VIDAZA nearly doubled the two-year survival rate for higher-risk MDS patients compared to conventional care regimens (CCR) with a mean survival of 24.5 months compared to 15 months for patients who received CCR.

"We are very encouraged by the CHMP's recommendation for marketing approval for VIDAZA," said Kathy Heptinstall, Operating Director of the Myelodysplastic Syndromes Foundation, "The MDS Foundation is committed to making sure that patients in need are aware of and have access to new treatments, like VIDAZA, that can help patients to live longer and allow them to have a better quality of life."

The AZA-001 trial also showed that, VIDAZA delays the progression of MDS to acute myeloid leukemia (AML). Roughly 30 percent of patient diagnosed with MDS will progress to AML. The delay in progression is especially significant because patients with MDS are typically over the age of 65. According to the National Institute of Health, in this patient group, the average 5-year survival rate after diagnosis with AML is only approximately four percent.

MDS is a primary neoplasm of the bone marrow that is more prevalent than any of the leukemias. MDS affects the function of blood cells; red blood cells, white blood cells or platelets. The incidence of MDS is underestimated.

About The MDS Foundation

The Myelodysplastic Syndromes Foundation, Inc. is a multi-disciplinary, international organization devoted to the prevention, treatment, and study of the myelodysplastic syndromes. The organization is based upon the premise that international cooperation will accelerate the process leading to the control and cure of these diseases. For further information, please visit http://www.mds-foundation.org.

Source
Kathy Heptinstall
Operating Director
The MDS Foundation, Inc.