FDA approves Rituxan (Rituximab)

Genentech and Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) has approved, following Priority Review, the therapeutic antibody Rituxan (Rituximab) in combination with methotrexate (MTX) to reduce signs and symptoms in adult patients with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

Rituxan is the first treatment for RA that selectively targets immune cells known as CD20-positive B-cells. Through this unique mechanism of action, Rituxan may affect multiple pathways by which B-cells are believed to contribute to the initiation and development of RA.

"The FDA approval of Rituxan for RA provides an important new treatment approach for patients who do not respond adequately to TNF antagonist therapy," said Stephen Paget, M.D., chairman, professor of medicine and physician-in-chief at the department of medicine, division of rheumatology, at the Hospital for Special Surgery in New York. "In clinical trials, Rituxan demonstrated significant improvement in joint pain, inflammation and physical function from a single course of therapy in this difficult-to-treat patient population."

The FDA based its approval decision for Rituxan for RA on data from three randomized, double-blind, placebo-controlled studies of patients with active RA. Results of the pivotal Phase III trial known as REFLEX showed that a significantly greater proportion of patients who received a single treatment course of two infusions of Rituxan (1000 mg on days one and 15) with a stable dose of MTX achieved American College of Rheumatology (ACR) 20, 50 and 70 response rates compared to patients who received placebo and MTX. The study included patients with active RA who had an inadequate response or were intolerant to prior treatment with one or more TNF antagonist therapies and current MTX therapy.