Cancer Drug Vidaza(R) Receives Positive Opinion From European Regulatory Authority For Treatment Of MDS And AML

The positive opinion includes important survival data from the AZA-001 trial in higher-risk MDS patients. The CHMP, which reviews applications for all 27 Member States in the European Union (EU) as well as Norway and Iceland, has recommended approval for azacitidine. The CHMP's positive opinion will be forwarded to the European Commission, which generally follows the recommendation of the CHMP and typically issues final marketing approval within two to three months.