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Rituxan Phase II Data in Patients with Relapsing-Remitting Multiple,Sclerosis Presented at the American Academy of Neurology

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Severe mucocutaneous skin reactions, some with fatal outcome, have been reported in association with Rituxan treatment. Abdominal pain, bowel obstruction and perforation, in some cases leading to death, were observed in patients receiving Rituxan in combination with chemotherapy for diffuse large B-cell (DLBCL), CD20-positive NHL. Other serious or potentially life-threatening adverse reactions that have been reported following Rituxan therapy include cardiac arrhythmias, hepatitis B reactivation with fulminant hepatitis, and other viral infections.

JC virus infection resulting in PML and death has been reported in Rituxan-treated patients including those with hematologic malignancies or with certain autoimmune diseases such as systemic lupus erythematosus (SLE), an indication for which Rituxan has not been approved.

About Rituxan
Rituxan is a therapeutic antibody being studied in primary progressive MS, for which there is currently no FDA-approved therapy. Rituxan is also being studied in other autoimmune diseases with significant unmet medical needs, including SLE, lupus nephritis and ANCA-associated vasculitis.

Rituxan, discovered by Biogen Idec, 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. Rituxan received FDA approval in February 2006 for the treatment of diffuse large B-cell lymphoma (DLBCL) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens in previously untreated patients. In February 2006, Rituxan also received FDA approval in combination with methotrexate to reduce signs and symptoms in adult patients with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis
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