Europe Approves Roche’s Rheumatoid Arthritis Drug

The European Commission has approved a new indication for Roche’s rheumatoid arthritis drug RoActemra to treat patients in the early phase of the disease.

The latest approval for RoActemra (tocilizumab) applies to patients with severe, active and progressive RA who previously have not been treated with methotrexate, the company said. The drug is the first interleukin-6 receptor antagonist approved in Europe for early RA, when treatment may change the course of disease and prevent irreversible damage to joints and long-term disability, Roche said.

The new indication was based on a study that showed RoActemra treatment with and without methotrexate achieved greater inhibition of structural joint damage compared with methotrexate alone.

In April, the subcutaneous formulation of RoActemra received EC approval for treatment of moderate to severe RA in patients who are either intolerant to or have failed to respond to other treatments.

RA is an autoimmune disease that affects about 40 million people worldwide. — Jonathon Shacat

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.