Roche receives EU approval for new RoActemra indication

Roche has announced that its rheumatoid arthritis drug RoActemra has been approved by the European Commission in a new indication.

The drug has been ratified for use in patients with severe, active and progressive rheumatoid arthritis who previously have not been treated with methotrexate, allowing it to be used at an earlier stage of treatment.

It becomes the first interleukin-6 receptor antagonist to be approved for use in Europe in patients with early rheumatoid arthritis. This will help patients to prevent irreversible damage to joints and long-term disability.

Data from the phase III FUNCTION trial has underlined the efficacy of RoActemra among this patient group. The approval represents the fifth update and expansion to the product's European label in three years.

Dr Sandra Horning, head of global product development and chief medical officer at Roche, said: "RoActemra is an effective biologic treatment for patients with early rheumatoid arthritis that may change the course of disease and reduce the likelihood of disability."

This comes after the company's drug Avastin was approved in Europe for the treatment of platinum-resistant recurrent ovarian cancer last month.