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Biogen Idec and Genentech Submit a Supplemental Biologics License Application for FDA Review of Rituxan(R) for the Treatment of Rheumatoid Arthritis.

CAMBRIDGE, Mass. and SOUTH SAN FRANCISCO, Calif., Aug. 31 /PRNewswire-FirstCall/ -- Biogen Idec, Inc. and Genentech, Inc. announced today that the companies submitted a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for a new indication for Rituxan(R) (Rituximab) in patients with active rheumatoid arthritis (RA) who inadequately respond to an anti-TNF therapy.

The sBLA submission is based primarily on the 24-week results of a multi-center, randomized, double-blind, placebo-controlled Phase III study known as REFLEX. In the trial, patients who received a single course of two infusions of Rituxan with a stable dose of ...

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