14 October 2016 - The TGA has published an AusPAR for the new formulation of Roche's Actemra (tocilizumab).

The TGA approved the new formulation (subcutaneous injection) of Actemra on 19 January 2016:

• for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease-modifying anti- rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs.
  
• for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors in combination with MTX in those not previously treated with MTX.
  

In the two groups of patients above, Actemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

Actemra has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate.

Read AusPAR for Actemra