Roche's RoActemra gains EU approval for use in early RA

The European Commission has approved Swiss pharma major Roche’s (ROG: SIX) RoActemra (tocilizumab) 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, says Roche. Sales of Actemra/RoActemra grew 22% to 568 million francs ($610.7 million) for the first half of 2014. The early RA approval is the fifth update and expansion to RoActemra's European label in three years, the company noted.

“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,” she noted.