GSK files for EU approval of sirukumab in rheumatoid arthritis

GlaxoSmithKline (LSE: GSK) today announced the regulatory submission of a Marketing Authorization Application (MAA) to the European Medicines Agency 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), a subsidiary of Johnson & Johnson (NYSE: JNJ) under an agreement signed in December 2011. Under the terms, GSK has exclusive rights to commercialize sirukumab in North, Central and South America, while Janssen retains commercialization rights in the rest of the world, including Europe. Global profit will be shared equally between the two companies. Prior to the agreement, Janssen had been developing sirukumab for RA.

Paul-Peter Tak, GSK’s chief immunology officer and senior vice president R&D pipeline, said: “We have worked with our partner Janssen to develop a robust regulatory package to support the use of sirukumab in adult patients who, despite the use of conventional and biologic therapies, still suffer from moderately to severely active rheumatoid arthritis. We believe sirukumab, if approved, will provide these patients with a once every four week subcutaneous treatment option.”