GlaxoSmithKline has confirmed a US regulatory submission for sirukumab in rheumatoid arthritis.
GSK says a biologics licence application has been submitted to the US Food and Drug Administration by Janssen Biotech Inc.
This seeks approval of a 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) who have failed or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Sirukumab is being co-developed for RA as part of a collaboration with Janssen Biologics (Ireland), an affiliate of JBI.
GSK's chief immunology officer and senior vice-president R&D pipeline, Paul-Peter Tak, said: "We are pleased with the progress being made to seek regulatory approval of sirukumab in adult patients who, despite the use of conventional and biologic therapies, still suffer from moderately to severely active rheumatoid arthritis.
"If approved, sirukumab would provide these patients with another treatment option. This US submission follows one made for Europe earlier this month and we look forward to the outcome of the regulatory authority reviews."
At 1:07pm: (LON:GSK) GlaxoSmithKline PLC share price was -0.75p at 1648.25p