Roche wins early use RA approval for RoActemra in Europe

Roche's arthritis brand RoActemra (tocilizumab) has widened its European licence, winning a new EU indication to treat early rheumatoid arthritis.

The European Commission approval covers the drug's use for patients with severe, active and progressive RA who previously have not been treated with methotrexate. It marks RoActemra's fifth European label expansion in three years.

Sandra Horning, Roche's head of global product development and chief medical officer, said: “RoActemra is an effective biologic treatment for patients with early RA that may change the course of disease and reduce the likelihood of disability.

“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.”

Last year sales of RoActemra rose 30% to top 1bn Swiss francs ($1.1bn), but it has a long way to go before it catches up with Humira, Remicade and Enbrel. The anti-TNFs are currently the three biggest-selling pharma products in the world with combined revenues last year of around $30bn.

RoActemra's latest approval was based on data from the phase III FUNCTION study, which assessed its efficacy, safety and prevention of structural joint damage in patients with early moderate-to-severe RA not previously treated with methotrexate.

The study showed patients on the combination experienced a significantly greater improvement in disease activity (DAS28 remission) after 24 weeks compared to patients who received methotrexate alone - meeting the study's primary endpoint.

Roche said its data also showed that treatment with RoActemra - with and without methotrexate - achieved greater inhibition of structural joint damage compared with methotrexate alone.

The company added that treating rheumatoid arthritis at such a critical early phase could prevent irreversible damage to joints and long-term disability.