Genentech gets FDA approval for Rituxan

Genentech’s arthritis treatment Rituxan has been approved by the US Food and Drug Administration (FDA), the firm announced Tuesday.

The drug, which had been given a priority review by the agency, was approved under an indication to treat symptoms of moderate-to-severe rheumatoid arthritis (RA) and have responded poorly to tumour necrosis factor antagonist drugs.

During phase III clinical trials, Genentech discovered the majority of RA patients to achieve significant improvements compared to patients receiving a placebo, when used with a stable dose of methotrexate (MTX).

Stephen Paget of the Hospital for Special Surgery in New York said: “The FDA approval of Rituxan for RA provides an important new treatment approach for patients who do not respond adequately to TNF antagonist therapy.

“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 drug works by targeting B-cells ? immune system cells which the company found can play a role in RA development. In some cases, B-cells encourage an immune system attack against the body’s own tissues through the production of antibodies.

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