The Committee for Medicinal Products for Human Use’s (CHMP’s) positive opinion is based on data from the AZA-001 trial, which has demonstrated an overall survival benefit for higher-risk myelodysplastic syndromes (MDS) patients.
The positive opinion will be forwarded to the European Commission that generally follows the recommendation of the CHMP and issues final marketing approval.
John Huber, executive director of the Aplastic Anemia & MDS International Foundation, said: “We are excited by Vidaza’s positive CHMP opinion because there are few treatment options for patients in Europe with this disease. Vidaza not only extends patients’ lives, but also improves their quality of life. We are hopeful that Vidaza will receive marketing approval shortly and quickly be available for patients across Europe.”