Genentech and partner Biogen Idec say they have filed a supplemental Biologics License Application with the US Food and Drug Administration for a new indication for its anticancer agent Rituxan (rituximab) in patients with active rheumatoid arthritis who inadequately respond to therapy with an anti-tumour necrosis factor drug, including Wyeth and Amgen’s Enbrel (etanercept).
The dossier includes data from a 24-week, Phase III study known as Reflex. In the trial, patients who received a single course of two infusions of Rituxan with a stable dose of methotrexate displayed a statistically significant improvement in symptoms measured at 24 weeks, compared to those receiving placebo and methotrexate [[07/04/05a]], [[10/06/05f]].
Rituxan - which is also being investigated in other autoimmune diseases, including lupus and multiple sclerosis - earned $450 million for Genentech during the second quarter alone, up 15% [[12/07/05a]]. The compound first received FDA approval in November 1997 for relapsed or refractory low-grade or follicular, B-cell non-Hodgkin's lymphoma. Recently, Genentech and Biogen Idec submitted a regulatory filing for the FDA review of Rituxan for the first-line treatment of intermediate grade or aggressive B-cell NHL [[18/08/05f]].