Switzerland’s Roche this morning revealed it has filed for European approval of its top-selling anticancer agent, MabThera (rituximab) in patients with difficult-to-treat rheumatoid arthritis.
This filing follows positive results from the REFLEX study which showed that MabThera is highly effective in relieving symptoms amongst patients who have had an inadequate response or are intolerant to prior treatment with one or more anti-TNF (biologic) therapies, including Wyeth/Amgen’s Enbrel (etanercept) [[07/04/05a]], [[10/06/05f]]. Most important, the benefits are seen after only a short treatment course of two infusions, notes Roche, adding that the results of the REFLEX trial will be presented at the American College of Rheumatology meeting in San Diego in November.
RA affects more than 21 million people worldwide, with up to 2 million sufferers in Europe alone. Of the RA patients treated with current biologic therapy, about 30% do not have a satisfactory outcome and at present have few treatment alternatives remaining, says Roche. “MabThera offers a unique new treatment for patients with rheumatoid arthritis in that it selectively targets B cells, providing a fundamentally different approach for managing painful and swollen arthritic joints.”
Roche’s partners, Genentech and Biogen Idec, also recently submitted a US filing for the drug in this new label – which will mark a significant opportunity for the firms [[01/09/05f]]. The market for RA drugs is currently worth some $5.5 billion and is forecast to almost double to $10.5 billion by 2008.