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.
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