GSK and Janssen seek European approval for sirukumab in rheumatoid arthritis

Sirukumab is a human monoclonal IgG1 kappa antibody that targets the cytokine IL-6, a naturally occurring protein that is thought to play a role in autoimmune conditions such as RA.

The companies are seeking 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 for whom treatment with methotrexate is not appropriate.

Approval is being sought for the subcutaneous formulation of sirukumab in two presentations, a single-dose prefilled syringe and a single-dose autoinjector.

The MAA was based on a phase III clinical development program, which included over 3,000 patients.

GSK chief immunology officer & senior vice president of R&D pipeline Paul-Peter Tak 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.”

GSK and Janssen entered into a licensing and co-development agreement in December 2011 with respect to sirukumab. 

The deal granted GSK exclusive rights to commercialize sirukumab in North, Central and South America. Janssen retains commercialization rights in the remaining parts of the world, including Europe.

The companies agreed to share global profit equally. GSK is planning to make an US application for sirukumab, which is currently not approved as a treatment for any indication anywhere in the world, later this year.

Image: Film X-ray knee joint with arthritis. Photo: courtesy of stockdevil at FreeDigitalPhotos.net.