Genentech, Biogen Idec Drug Fails In Lupus Nephritis Trial
Lupus nephritis is an inflammation of the kidney and a complication of systemic lupus erythematosus, called SLE or lupus, an autoimmune disease. Lupus nephritis can lead to a progressive loss of kidney function and may result in kidney failure in the most severe cases. Lupus nephritis occurs in around one-third of people with SLE.
The primary endpoint of the trial evaluated improvements in kidney response as measured by standard laboratory tests used to assess kidney health. A preliminary analysis of the safety data did not reveal any new or unexpected safety signals in patients receiving Rituxan.
Genentech executive Hal Barron expressed his company's disappointment in the results and said, " Using the insights from this study, we will continue to look for new approaches to the treatment of lupus."
The Phase III randomized, double-blind, placebo-controlled, multi-center study included 144 patients with Class III or IV lupus nephritis from around 60 sites in the U.S., Canada, Mexico, Argentina and Brazil.
Rituxan, which was discovered by Biogen Idec, is a therapeutic antibody that first received FDA approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma. It was also approved in the European Union under the trade name MabThera in June 1998.
The drug is being studied in other autoimmune diseases with significant unmet medical needs, including antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
Genentech and Biogen Idec co-market Rituxan in the United States, and Roche markets MabThera in the rest of the world, except Japan, where Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.
South San Francisco, California-based Genentech is a biotechnology company that discovers, develops, manufactures and commercializes medicines.
Cambridge, Massachusetts-based Biogen Idec is engaged in the discovery, development, manufacturing and commercialization of therapies that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis.
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