The submission to the FDA is based on existing clinical data and new studies recently completed by Pharmion.
Vidaza was approved by the FDA in 2004 for the treatment of patients with myelodysplastic syndromes (MDS) a group of diseases characterized by their adverse affect on the production of healthy blood cells, and the risk of transformation into leukaemia.
“We are pleased to be seeking an approval for physicians to administer Vidaza via an IV infusion of less than one hour, and thus give two convenient options for the delivery of Vidaza,” said Patrick Mahaffy, Pharmion’s president and CEO. “We believe that providing this kind of flexibility within the label will be very important to physicians and their patients.”
Under the NDA submission, the dosing for Vidaza would remain the same at 75mg/m2 daily, for seven days, every four weeks. Pharmion anticipates a response from the FDA within the standard review time for an NDA supplement of six to ten months from the date of the submission.