Roche has filed first rheumatoid arthritis indication for MabThera in Europe following positive results from the REFLEX study which showed that MabThera is highly effective in relieving symptoms in patients who have had an inadequate response or are intolerant to prior treatment with one or more anti-TNF (biologic) therapies. Most important, the benefits are seen after only a short treatment course of two infusions, the company announced here.
“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. A successful regulatory outcome will allow physicians and patients an alternative option for tackling this debilitating disease," commented Eduard Holdener, head of Global Pharma Development in Roche’s Pharmaceutical Division.
The regulatory filing of MabThera for patients with the most difficult-to-treat RA is to support the first indication of MabThera in rheumatoid arthritis and marks the beginning of a new opportunity for Roche in this therapeutic area. Genentech and Biogen Idec have also recently submitted a US filing for Rituxan (rituximab’s name in the US), said the release.
MabThera has a strong heritage in the treatment of a form of lymphatic cancer called non-Hodgkin’s lymphoma (NHL) where over 730,000 patients have been treated with MabThera to date.