Celgene Corporation received a notification from the US FDA that the action date for its priority review of the New Drug Application (NDA) for Revlimid (lenalidomide), for the treatment of patients with 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, has been extended to January 7, 2006. The original action date under the Prescription Drug User Fee Act (PDUFA) for the Revlimid NDA was October 7, 2005.
The extension is a result of the FDA requiring more time to review additional information on Celgene's RevAssist risk-management programme, claims a company release.
Revlimid is a member of a new class of novel IMiDs, immunomodulatory drugs. It is a derivative of thalidomide, a drug associated with birth defects, and the delay in approval for MDS is designed to satisfy the FDA that a fetus would not be exposed to the drug.
Celgene Corporation is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialisation of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation.