FDA Approval of Rituxan for Wegener’s and Microscopic Polyangiitis

FDA Approval of Rituxan for Wegener’s and Microscopic Polyangiitis

April 2011

On April 19, 2011, the U.S. Food and Drug Administration approved the drug, Rituxan®, (rituximab) in combination with glucocorticosteroids for the treatment of two forms of ANCA-associated vasculitis: granulomatosis with polyangiitis (Wegener’s) and microscopic polyangiitis.

Rituxan is the first FDA-approved drug for any form of vasculitis, a family of 15+ rare autoimmune diseases that can affect people of all ages. There is no known cause or cure for vasculitis. Rituxan works by affecting the action of and eliminating B cells, which are cells of the immune system that have a number of actions. It was initially developed for treatment of a type of lymphoma, and since has been found to be effective for autoimmune diseases, including rheumatoid arthritis and now ANCA-associated vasculitis. While Rituxan has a generally good track record for safety and effectiveness, like other drugs that affect the immune system, it can cause a variety of side effects. Some of the FDA warnings include infusion reactions, rashes and sores in the skin and mouth; and a rare brain infection called progressive multifocal leukoencephalopathy. Rituxan should not be used in patients with severe, active infections.

ANCA-associated vasculitis (AAV), that primarily affects the small blood vessels, includes the diseases granulomatosis with polyangiitis (Wegener’s), microscopic polyangiitis and Churg Strauss syndrome.

Joyce Kullman, executive director of the Vasculitis Foundation (VF), said, “This is the first FDA-approved drug for any form of vasculitis, and the VF is delighted for our patients and their families. The VF thanks the dedicated patients who participated in the study trials and the many researchers committed to improving treatments for our patients.”

“Although the approval of Rituxan is encouraging, it has only been approved for two of the vasculitic diseases. We hope Rituxan is the first of many drugs that will augment and eventually replace the current standard treatments of corticosteroid, cytotoxic and immunosuppressive drugs that have so many and sometimes devastating side effects for our patients.”

Rituxan is manufactured by San Francisco-based Genentech, a member of the Roche Group.

Click here to read the FDA announcement.