GSK Reports EU Regulatory Submission For Sirukumab In Rheumatoid Arthritis

(RTTNews) - GlaxoSmithKline plc (GSK, GSK.L) announced the regulatory submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of subcutaneous formulation of sirukumab, a human anti-interleukin (IL)-6 monoclonal antibody, for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

The MAA 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 (DMARDs) and as a monotherapy in these patients for whom treatment with methotrexate is inappropriate.

Sirukumab is being co-developed for RA as part of a collaboration with Janssen Biologics (Ireland).

Approval is being sought for the subcutaneous formulation of sirukumab in two presentations, a single-dose prefilled syringe and a single-dose autoinjector. The data to support the file are based on a comprehensive phase III clinical development programme involving more than 3,000 patients.

A regulatory submission to the United States Food and Drug Administration is also planned for 2016. Sirukumab is currently not approved as a treatment for any indication anywhere in the world.