FDA approves Rituxan as first targeted B-cell therapy for treatment of rheumatoid arthritis
Genentech, Inc. and Biogen Idec, Inc. announced today that the U.S. food and Drug Administration (FDA) has approved, following Priority Review, the therapeutic antibody Rituxan® (Rituximab) in combination with methotrexate (MTX) to reduce signs and symptoms in adult patients with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Rituxan is the first treatment for RA that selectively targets immune cells known as CD20-positive B-cells. Through this unique mechanism of action, Rituxan may affect multiple pathways by which B-cells are believed to contribute to the initiation and development of RA.
Rituxan, discovered by Biogen Idec, is a therapeutic antibody that targets and selectively depletes CD20-positive B-cells without targeting stem cells or existing plasma cells. In patients with RA, Rituxan is given as two 1000 mg IV infusions separated by two weeks, in combination with MTX. It is recommended to administer the steroid methylprednisolone 100 mg IV 30 minutes prior to each infusion. In addition to RA, Rituxan is being studied in other autoimmune diseases with significant unmet medical needs, including systemic lupus erythematosus, lupus nephritis, multiple sclerosis and ANCA-associated vasculitis.
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