Genentech and Biogen Idec are seeking a priority review for use of their oncologic Rituxan (rituximab) for treatment of active rheumatoid arthritis in patients who are not responsive to anti-tumor necrosis factor therapy.

The companies' supplemental BLA submission was announced Aug. 31. Assuming a priority review is granted, approval could come by February 2006.

The sBLA is based on the 24-week, Phase III REFLEX study, which demonstrated a statistically significant improvement in symptoms for patients receiving two infusions of Rituxan in combination with methotrexate compared to placebo plus methotrexate.

REFLEX results will be presented at the American College of Rheumatology meeting Nov. 12-17 in San Diego.

The rheumatoid arthritis submission is the second sBLA for Rituxan filed within the last two weeks.

On Aug. 17, Genentech and Biogen Idec announced submission of an sBLA for front-line treatment of intermediate-grade or aggressive, CD-20 positive, B-cell, non-Hodgkin's lymphoma in combination with chemotherapy (¹ Also see "Genentech/Biogen Idec Submit Rituxan sBLA For Front-Line Non-Hodgkin’s Lymphoma" - Pink Sheet, 17 August, 2005.).

The biologic also is being investigated as a treatment for other autoimmune diseases, including lupus, multiple sclerosis and vasculitis.

Rituxan currently is approved for relapsed or refractory, low-grade or follicular, CD-20 positive, B-cell NHL. The agent generated global sales of $1.71 bil. in 2004.

- Jon Dobson

Genentech/Biogen Idec Submit Rituxan sBLA For Rheumatoid Arthritis

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