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news.Roche's MabThera has been approved by the European Commission for the treatment of rheumatoid arthritis in Europe, making it the first and only selective B-cell therapy available for this indication.
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MabThera (rituximab) in combination with methotrexate is now indicated for the treatment of adult patients with severe active rheumatoid arthritis (RA) who have had an inadequate response or are intolerant to current treatment options including one or more tumor necrosis factor (TNF) inhibitors.
MabThera is the first and only selective B-cell therapy for RA, offering a fundamentally different treatment approach. B-cells play a key role in driving the RA disease process and MabThera is thought to break this process.
The European approval of MabThera is based on impressive results from the REFLEX1 trial, in which MabThera plus methotrexate was shown to be a highly effective therapy for controlling symptoms and improving the physical and mental health of patients with RA. US approval was secured earlier this year.
“Due to the high number of patients who do not respond or tolerate currently available therapies, there is a great need for novel and effective options,” said William Burns, CEO of Roche’s pharmaceutical division. “We are confident that MabThera, Roche’s first innovative treatment for RA, will bring relief to patients with this debilitating disease and that our ongoing R&D programs will yield more therapies for those who need them.”
A comprehensive phase III clinical development program is currently underway to further investigate the potential clinical benefit of MabThera in earlier RA.
In related news, Roche also announced that MabThera has been approved in Europe as maintenance therapy for patients with relapsed or refractory follicular non-Hodgkin’s lymphoma.