Participating Clinical Centers
FDA Approves Pharmion's Vidaza(TM) for the Treatment of MDS
May 19, 2004
Pharmion Corporation today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market Vidaza (azacitidine for injectable suspension) for the treatment of Myelodysplastic Syndromes (MDS). Vidaza is the first drug approved for the treatment of MDS. Vidaza is an orphan product. Orphan products are developed to treat rare diseases, or conditions that affect fewer than 200,000 people in the U.S. The Orphan Drug Act provides a seven-year period of exclusive marketing to the first sponsor who obtains marketing approval for a designated orphan drug. Pharmion intends to make Vidaza commercially available within several weeks.
Vidaza is believed to exert its anticancer effects by causing demethylation, or hypomethylation, of DNA in abnormal blood-forming (hematopoietic) cells in the bone marrow as well as through its direct cytotoxic effect. Demethylation may restore normal function to tumor- suppressor genes which are responsible for regulating cell differentiation and growth. The cytotoxic effects of azacitidine cause the death of rapidly- dividing cells, including cancer cells that are no longer responsive to normal growth control mechanisms. Non-proliferating cells are relatively insensitive to Vidaza.
Find out more by visiting the FDA web site, and the Pharmion's web site and search under "Recent News."
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