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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.
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PR Newswire
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August 31, 2005
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Copyright informationCOPYRIGHT 2005 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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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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