CNTO 136 (sirukumab) filed with EU for rheumatoid arthritis- GlaxoSmithKline / Janssen

GlaxoSmithKline and Janssen announced the regulatory submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of subcutaneous formulation of CNTO 136 (sirukumab) 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.

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.