Biogen Idec Inc and Genentech Inc, makers of the therapeuticantibody Rituxan, submitted a supplemental biologicslicense application with the FDA acknowledging a newindication for Rituxan—as a treatment for rheumatoidarthritis (RA) in patients who do not respond properly toanti-tumor necrosis factor (anti-TNF) therapy. The manufacturersbased their claims on results of a 24-week, multicenter,randomized, double-blind, placebo-controlled phase3 study known as REFLEX. The study measured patientresponse to a single course of 2 infusions of Rituxan plus adose of methotrexate and found a statistical improvementof symptoms in 24 weeks, compared with a combination ofplacebo plus methotrexate. According to Genentech'sSenior Vice President and Chief Medical Officer Hal Barron,MD, "Rituxan may provide a potential new treatmentapproach for the RA patient population with the greatestunmet medical need."
Ms. Farley is a freelance medical writer based in Wakefield, RI.