European Commission Approves RoACTEMRA for Treatment of RA

September 9, 2014
BioPharm International Editors

Roche?s RoACTEMRA receives EU approval for use in patients with early rheumatoid arthritis.

Roche announced on Sept. 8, 2014 that the European Commission (EC) has approved RoACTEMRA (tocilizumab) for use in patients with severe, active, and progressive rheumatoid arthritis (RA) who previously have not been treated with methotrexate (MTX). RoACTEMRA is the first interleukin-6 (IL-6) receptor antagonist to be approved for use in Europe in patients with early RA.

“RoACTEMRA is an effective biologic treatment for patients with early RA that may change the course of disease and reduce the likelihood of disability,” said Sandra Horning, MD, head of global product development and chief medical officer at Roche, in a press release. “As the first IL-6 receptor antagonist approved for early RA, RoACTEMRA addresses the need for alternative treatment options to anti-tumor-necrosis-factor (anti-TNF) therapies in this debilitating condition.”

According to Roche, the EC approved the biologic based on data from the Phase III Function study, which assessed the efficacy, safety, and prevention of structural joint damage in patients with early moderate-to-severe RA (defined as ≤2 years since diagnosis) not previously treated with MTX. The early RA approval is the fifth update and expansion to RoACTEMRA's European label in three years.

Source: Roche