Posted by Michael Wonder on 12 Sep 2016
GSK announces EU regulatory submission for sirukumab in rheumatoid arthritis
12 September 2016 - GSK today announced the regulatory submission of a marketing authorisation application to the EMA seeking approval of subcutaneous formulation of sirukumab, a human anti-interleukin-6 monoclonal antibody, for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
The marketing authorisation application seeks approval for sirukumab in combination with methotrexate in RA patients who have failed or are intolerant to conventional or biologic disease-modifying antirheumatic drugs and as a monotherapy in these patients for whom treatment with methotrexate is inappropriate.
Sirukumab is being co-developed for rheumatoid arthritis as part of a collaboration with Janssen.
