EMEA accepts Vidaza for accelerated review

USA-based Pharmion says that the European Medicines Agency (EMEA) has accepted its myelodysplastic syndrome drug Vidaza (azacitidine for injection) for review. The firm, which is seeking approval for the drug in patients with higher-risk forms of the condition, said that the EMEA is to consider its application under the Accelerated Assessment Procedure.

Pharmion said that its submission to the EMEA includes data from a Phase III multicenter study which demonstrated Vidaza's superiority in terms of survival benefit to conventional care regimens (Marketletter December 17, 2007).

The drug, which has been designated an Orphan Medicinal Product for MDS, was approved by the US Food and Drug Administration in May 2004 (Marketletters passim).