Revlimid New Drug Application Submitted to FDA for Review

Celgene has completed the rolling submission of its new drug application (NDA) for Revlimid to the FDA for review.

The company's NDA is seeking approval to market Revlimid (lenalidomide) as a treatment for transfusion-dependent patients with myelodysplastic syndromes (MDS) with a 5q deletion chromosomal abnormality.

MDS is a malignant disorder of blood cell production that affects approximately 300,000 people worldwide. The most common clinical manifestation associated with MDS is refractory anemia, and the multiple complications that stem from frequent blood transfusions. Celgene's lead IMiD (Immunomodulatory drug), Revlimid has received both orphan-drug status and fast-track designation from the FDA and orphan-drug status from the European Medicines Agency for the treatment of MDS.