Biogen Idec Inc and Genentech Inc, makers of the therapeutic antibody Rituxan, submitted a supplemental biologics license application with the FDA acknowledging a new indication for Rituxanas a treatment for rheumatoid arthritis (RA) in patients who do not respond properly to anti-tumor necrosis factor (anti-TNF) therapy. The manufacturers based their claims on results of a 24-week, multicenter, randomized, double-blind, placebo-controlled phase 3 study known as REFLEX. The study measured patient response to a single course of 2 infusions of Rituxan plus a dose of methotrexate and found a statistical improvement of symptoms in 24 weeks, compared with a combination of placebo plus methotrexate. According to Genentech's Senior Vice President and Chief Medical Officer Hal Barron, MD, "Rituxan may provide a potential new treatment approach for the RA patient population with the greatest unmet medical need."
Ms. Farley is a freelance medical writer based in Wakefield, RI.
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