The European Medicines Agency (EMEA) has accepted for review Celgene Corporations' marketing authorisation application (MAA) for Revlimid (lenalidomide), submitted in August 2005. The application is based on clinical data from an open-label Phase II trial, evaluating Revlimid in the largest clinical trial to date of MDS patients with deletion 5q chromosomal abnormality.
Celgene is seeking authorisation to market Revlimid as a treatment for transfusion-dependent anaemia due to low- or intermediate-1- risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, claims a company release.
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 anaemia, and the multiple complications that stem from frequent blood transfusions. Revlimid has been designated as an orphan medicinal product in the European Union (EU) for the treatment of MDS.
Revlimid also has been designated as an orphan medicinal product in the EU for the treatment of multiple myeloma (MM). Celgene expects to file its supplemental new drug application (sNDA) and MAA for REVLIMID in previously treated patients with relapsed and refractory MM to the FDA in fourth quarter 2005, and to the EMEA in first quarter 2006.
"Celgene looks forward to working with the EMEA as it begins the review process for Revlimid. We appreciate the efforts of all the people who made this filing possible, and acknowledge the commitment from all participants in these MDS studies, who helped Revlimid get to this stage in the European regulatory process." said Graham Burton, senior vice president, regulatory affairs and pharmacovigilence for Celgene Corporation.
Revlimid is a member of a new group of proprietary compounds of Celgene Corporation. These novel compounds or IMiDs are compounds that have diverse biological properties, including immunomodulatory properties.
Celgene continues to evaluate treatments with Revlimid for a broad range of haematology and oncology conditions, including; multiple myeloma, the malignant blood cell disorders known as myelodysplastic syndromes (MDS), chronic lymphocytic leukaemia as well as solid tumour cancers. Revlimid affects multiple intracellular biological pathways. Revlimid is not approved by the FDA or any other regulatory agencies as a treatment in any indication and is currently being evaluated in clinical trials for efficacy and safety for future regulatory applications.