Application to be reviewed under European Accelerated Assessment Procedure
BOULDER, Colo., Feb. 7 /PRNewswire-FirstCall/ -- Pharmion Corporation (Nasdaq: PHRM) today announced that the European Medicines Agency (EMEA) has accepted for review the Company's Marketing Authorization Application (MAA) for Vidaza(R) (azacitidine for injection) in patients with higher-risk myelodysplastic syndromes (MDS) and announced its intent to review the application under the Accelerated Assessment Procedure. Pharmion submitted the Vidaza MAA to the EMEA earlier this month.
The Accelerated Assessment Procedure 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 authorization application evaluation, the CHMP may decide to continue the assessment under standard centralized procedure timelines.
The application is based upon clinical data which include the results from the Company's Phase 3 multi-center, international, randomized study of Vidaza(R) (azacitidine for injection) in the treatment of patients with higher-risk MDS. The primary objective of this Phase 3 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
|SOURCE Pharmion Corporation|
Copyright©2008 PR Newswire.
All rights reserved