GlaxoSmithKline (GSK) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its product sirukumab, a subcutaneous formulation for adults with moderate to severe rheumatoid arthritis (RA).
The MAA seeks approval for sirukumab to be used with methotrexate (MTX) in patients with RA who have failed or are intolerant to conventional or biologic disease-modifying antirheumatic drugs (DMARDs), and also as a single agent in patients for whom MTX treatment is unsuitable.
Sirukumab is a human anti-interleukin (IL)-6 monoclonal antibody, a protein involved in autoimmune diseases. GSK is partnering with Janssen Biologics in Ireland to develop the drug for adults with rheumatoid arthritis.
GSK is seeking EMA approval for the subcutaneous formulation of sirukumab in two presentations, a single-dose autoinjector and a single-dose prefilled syringe. The submission was based on data from a Phase 3 clinical development program involving more than 3,000 rheumatoid arthritis patients.
The Phase 3 clinical development program included five clinical trials (SIRROUND-D, SIRROUND-T, SIRROUND-H, SIRROUND-M [Japan] and SIRROUND-LTE) in patients with active RA that received sirukumab (50 or 100 mg) administered subcutaneously with conventional DMARDs or as a single-agent every four or two weeks.
Top-line findings of SIRROUND-D, SIRROUND-T and SIRROUND-H were reported in late 2015 and primary findings from the SIRROUND-D trial were reported in June this year. Primary findings from the SIRROUND-T and SIRROUND-H trials will be presented at a future scientific conference. Comprehensive results for all five trials will be submitted for publication in peer-reviewed journals.
GSK is also planning to submit sirukumab for regulatory approval this year to the U.S. Food and Drug Administration (FDA).
“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,” Paul-Peter Tak, GSK’s chief immunology officer and senior vice president of its R&D pipeline, said in a press release. “We believe sirukumab, if approved, will provide these patients with a once-every-four-week subcutaneous treatment option.”
Rheumatoid arthritis causes premature death and disability, and lowers the quality of life in the industrialized and developing world. It is a systemic inflammatory disease that manifests itself in multiple joints in the body. The inflammation usually affects the lining of the joints (synovial membrane), but can also affect other organs.
According to the Centers of Disease Control and Prevention, the prevalence of rheumatoid arthritis is believed to range from 0.4 to 1.3 percent worldwide, and in 2005 an estimated 1.5 million (0.6 percent) of U.S. adults ages 18 and older had RA.