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Pharmion Corporation have announced that the European Medicines Agency (EMEA) will review the company’s marketing authorisation application for Vidaza (azacitidine for injection), for patients with higher-risk myelodysplastic syndromes (MDS).
The review will be carried out under the Accelerated Assessment Procedure, which is granted for medicinal products that are expected to be of major public health interest, particularly from the point of view of therapeutic innovation.
Accelerated Assessment reduces the time limit for the Committee for Medicinal Products for Human Use (CHMP) to give an opinion from 210 days to 150 days.
At any time during the marketing authorisation application evaluation, the CHMP may decide to continue the assessment under standard centralised procedure timelines.
The application is based upon clinical data which include the results from Pharmion’s phase III multicentre, international, randomised study of Vidaza in the treatment of patients with higher-risk MDS.
The primary objective of this phase III trial was to demonstrate superiority in overall survival of Vidaza versus conventional care regimens, and these data were presented at the American Society of Hematology annual meeting in December 2007.
Vidaza has been designated as an Orphan Medicinal Product in the EU for the treatment of MDS, which, if approved, entitles the drug to ten years of market exclusivity for the approved indication.
Vidaza has also been designated as an Orphan Medicinal Product in the EU for the treatment of acute myeloid leukemia (AML).
