Celgene Corporation, an integrated biopharmaceutical company, announced that Revlimid (formerly known as Revimid), has been granted orphan drug designation by the European Commission (EC) for multiple myeloma (MM) following the favourable opinion of the European Agency for the Evaluation of Medicinal Products (EMEA). Revlimid is the lead development compound of a new class of novel immunomodulatory drugs, or ImiDs. Ongoing trials are evaluating Revlimid in the treatment of a broad range of conditions, including; multiple myeloma, the malignant blood cell disorders known as myelodysplastic syndromes (MDS) and metastatic melanoma.
Orphan drug status is granted by the EC to promote development of drugs to treat rare diseases or conditions. Orphan drug designation will entitle Revlimid to ten years of market exclusivity for an indication in multiple myeloma; protocol assistance by EMEA to optimize drug development in preparing a dossier that will meet regulatory requirements; facilitate access to the Centralized Procedure for the application for marketing approval; reduce fees associated with applying for marketing approval and protocol assistance; and secure a European Union research funding grant.
Multiple myeloma is the second most common blood cancer worldwide affecting approximately 150,000 people. About 74,000 new cases of multiple myeloma are diagnosed each year and an estimated 57,000 deaths were reported worldwide in 2002.
"The decision by the European Commission to grant Revlimid orphan drug status for multiple myeloma supports our efforts to move Revlimid as quickly as possible through the clinical and regulatory development process worldwide," said Sol Barer, president of Celgene Corporation. "We continue to be encouraged by the growing body of published and presented data on Revlimid by key opinion leaders at major medical meetings, and based on these findings, we are committed to accelerating wherever possible our efforts to help address the unmet medical needs of myeloma patients worldwide."
Multiple myeloma is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease. However, most patients with multiple myeloma have cells that produce a form of immunoglobulin called paraprotein (or M protein) that does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease is unknown. Multiple myeloma is the second most common cancer of the blood, representing approximately one per cent of all cancers and two per cent of all cancer deaths with a worldwide prevalence of approximately 150,000 cases. In the year 2002, there were an estimated 74,000 new cases of multiple myeloma worldwide. The estimated number of deaths from multiple myeloma in 2002 was 57,370 worldwide.