REVLIMID MARKETING AUTHORIZATION APPLICATION ACCEPTED BY EMEA

Celgene has reported that the European Medicines Agency has accepted for review the company's marketing authorization application for Revlimid (lenalidomide), submitted in August. The application is based on clinical data from an open-label Phase II trial, evaluating Revlimid in the largest clinical trial to date of patients with deletion 5q chromosomal abnormality. Celgene is seeking authorization to market Revlimid as a treatment for transfusion-dependent anemia due to low- or intermediate-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

MDS is a malignant disorder of blood cell production that affects approximately 67,000 people throughout Europe. The most common clinical manifestation associated with MDS is chronic refractory anemia, and the multiple complications that stem from frequent blood transfusions.