MabThera gets EU go-ahead for RA and NHL

Swiss drug major Roche says that MabThera (rituximab), its therapeutic antibody product, has been cleared by the European Commission for use in the treatment of rheumatoid arthritis. Specifically, the product is approved in combination with methotrexate for adult patients with severe active RA who are intolerant to, or have had an inadequate response to, currently available therapies, including one of more-tumor necrosis factor-based regimen.

The EC's decision is based on the findings of the Phase III REFLEX (Randomized Evaluation of Long-term Efficacy of Rituximab in RA) study, which was a randomized, placebo-controlled, multicenter evaluation of combined MabThera and methotrexate versus methotrexate alone (Marketletter July 3). The results of the program showed that treated patients achieved a statistically-significant improvement in symptoms, according to assessment via American College of Rheumatology criteria, after 24-weeks, in comparison with subjects receiving placebo and methotrexate. Roche noted that analysis of the data had not revealed any unexpected safety issues, but added that it would continue to monitor the product's safety profile over the long-term.

The firm said that RA is one of the most common forms of autoimmune disease, and is thought to affect around three million European citizens, up to 40% of whom do not respond satisfactorily to currently-available treatments.