Roche has announced that MabThera (rituximab) has been approved by the European Commission for the treatment of rheumatoid arthritis (RA) in Europe. MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or are intolerant to current treatment options including one or more tumor necrosis factor inhibitors.
The approval of MabThera is based on the results of the REFLEX1 trial where MabThera, in combination with methotrexate, was shown to be a highly effective therapy for controlling symptoms and improving the physical and mental health of patients with RA. FDA approval was received in the U.S. earlier this year.