CHMP Recommends Extended Use of Tocilizumab

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on April 25 recommended approval of a new indication for the arthritis drug tocilizumab (RoActemra, Roche).

The new indication, subject to approval by the European Commission, is for use of tocilizumab in combination with methotrexate (MTX) for the treatment of juvenile idiopathic polyarthritis (JIA; rheumatoid factor–positive or rheumatoid factor–negative and extended oligoarthritis) in patients 2 years of age and older who have responded inadequately to previous therapy with MTX. Tocilizumab can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate, the CHMP said.

Tocilizumab is already approved in Europe for the treatment of active systemic JIA (sJIA) in patients 2 years of age and older who have responded inadequately to previous therapy with nonsteroidal anti-inflammatory drugs and systemic corticosteroids, the CHMP noted.

It is also approved in combination with MTX for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have either responded inadequately to or were intolerant to therapy with other disease-modifying antirheumatic drugs or tumor necrosis factor-alpha antagonists. Tocilizumab can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

Tocilizumab is an interleukin 6 receptor–inhibiting monoclonal antibody. Reducing interleukin 6 reportedly relieves inflammation of the joints and some systemic effects of rheumatoid arthritis.

In announcing their favorable opinion on the new indication, the CHMP noted that tocilizumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with MTX.

Tocilizumab is also approved for various indications in the United States.