Just thought you might find this interesting.
Kathy
February 13, 2007
Intravenous Administration of Vidaza for MDS Approved
Pharmion Corporation has received approval for intravenous (IV) administration of Vidaza (azacitidine) for the treatment of all subtypes of MDS. The U.S. Food and Drug Administration (FDA) formally notified the company of this approval on January 26, 2007. This additional option fpr administration expands the drug’s prior approval, which covered subcutaneous injection only. Vidaza may now be administered intravenously over a period of 10 to 40 minutes in a clinic, hospital, or physician’s office.
With intravenous administration, the dosing for Vidaza will be the same as the previously approved subcutaneous administration at 75 mg/m2 daily, for seven days, every four weeks. Intravenous administration of Vidaza may give patients who were unable to tolerate subcutaneous administration an opportunity to try the drug. In earlier clinical trials, 35% of patients taking the drug subcutaneously had redness and inflammation of the skin at the injection site, and 13% had other injection site reactions.
Pharmion Corporation has also received FDA approval of its application to test an oral form of Vidaza.
In 2004, the FDA approved Vidaza, the first in a new class of drugs called demethylation agents, for the treatment of all five subtypes of MDS.
Patients with MDS who have questions about Vidaza should speak with their doctor.
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