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news.Following a priority review the FDA has granted approval to Genentech and Biogen Idec's therapeutic antibody Rituxan to be used in the treatment of rheumatoid arthritis. The approval expands on the drug's indication in non-Hodgkin's lymphoma.
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Rituxan has been specifically approved to be used in combination with methotrexate 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.
“The FDA approval of Rituxan for RA provides an important new treatment approach for patients who do not respond adequately to TNF antagonist therapy,” said Dr Stephen Paget, physician-in-chief at the department of medicine, division of rheumatology, at the Hospital for Special Surgery in New York. “In clinical trials, Rituxan demonstrated significant improvement in joint pain, inflammation and physical function from a single course of therapy in this difficult-to-treat patient population.”