The company has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) based on the data from the phase 3 Sirround clinical development program.
Sirukumab is being co-developed by GlaxoSmithKline and Janssen Biologics in a partnership that started in late 2011.
It is a human monoclonal IgG kappa antibody that binds to interleukin-6 (IL-6), a cytokine that is thought to play a key role in autoimmune conditions such as RA.
Janssen is seeking approval for the subcutaneous formulation of sirukumab in two presentations, a single-dose prefilled syringe and a single-dose autoinjector.
The phase 3 clinical development program involving over 3,000 patients includes five studies evaluating subcutaneously administered sirukumab 50 mg every four weeks and sirukumab 100 mg every two weeks in combination with conventional disease-modifying antirheumatic drugs (DMARDs) or as monotherapy.
Janssen Research & Development head of immunology development Newman Yeilding said: “We are committed to deepening our understanding of rheumatoid arthritis with the goal of applying new scientific learnings to advance treatments like sirukumab for people living with this inflammatory rheumatologic disease.
“We are pleased to submit an application for sirukumab to the U.S. Food and Drug Administration and look forward to working with the agency with the goal of bringing this new biologic therapy to patients in need of alternative treatment options.”
A regulatory submission to the European Medicines Agency (EMA) for sirukumab was made earlier this month. It is currently not approved as a treatment for any indication anywhere across the world.