GSK Announces EU Regulatory Submission for Sirukumab in RA

GlaxoSmithKline 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) [Janssen].

Paul-Peter Tak, GSK’s Chief Immunology Officer & 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.”

Sirukumab is an investigational human monoclonal IgG1 kappa antibody that selectively binds with high affinity to the IL-6 cytokine, a naturally occurring protein that plays a role in autoimmune conditions. It is one of the ~40 assets profiled to investors at GSK’s R&D event in November 2015 and belongs to the company’s immuno-inflammation portfolio – one of six core areas of scientific research and development alongside oncology, vaccines and infectious, respiratory and rare diseases.

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.