Roche announced that RoACTEMRA (tocilizumab) has received approval from the European Commission for use in patients with severe, active and progressive RA who previously have not been treated with methotrexate (MTX). Treating the disease at this critical early phase may prevent irreversible damage to joints and long-term disability. 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, head of global product development and chief medical officer at Roche. “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.”
The approval was based on data from the Phase 3 FUNCTION study, which assessed the efficacy, safety and prevention of structural joint damage in patients with early moderate-to-severe RA (defined as ≤ two years since diagnosis) not previously treated with MTX. The study met its primary endpoint, demonstrating that patients who received RoACTEMRA in combination with MTX or as a single agent therapy (monotherapy) experienced a significantly greater improvement in disease activity (DAS28 remission) after 24 weeks compared to patients who received MTX alone.
The data also demonstrated that treatment with RoACTEMRA with and without MTX achieved greater inhibition of structural joint damage compared with MTX alone. At 24 weeks, the overall safety of RoACTEMRA in this early RA population was consistent with its known safety profile seen previously in other RoACTEMRA studies in RA.
The early RA approval is the fifth update and expansion to RoACTEMRA’s European label in three years.
Date: September 8, 2014