Roche has announced that it has submitted a combined filing to the European health authorities (the European Medicines Agency) for three new indications to extend the label for MabThera to use as a first-line biologic therapy for patients with rheumatoid arthritis (RA).
The new filings are for patients who have not been treated with methotrexate (MTX), the current standard treatment option; those who have had an inadequate response to MTX; and for the prevention of joint damage across all RA patient populations.
Joint damage in RA often begins early in the disease, so it is critical to treat patients as early as possible to reduce symptoms and stop irreversible damage before it occurs. This damage can lead to permanent disability affecting patients' ability to carry out normal everyday activities such as walking or dressing.
MabThera (administered as courses of two infusions of 1000mg, with repeat treatment determined by disease activity) is already a well established therapeutic option when used later in the treatment algorithm. It is currently licensed for patients with moderate-to-severe disease who have not benefited from, or are intolerant to, one or more tumour necrosis factor (TNF) inhibitors. In this population, MabThera is the only RA therapy that has proven to offer the preservation of joint structure for patients, providing additional improvements in the signs and symptoms of RA with each repeat course of treatment.