- Janssen Biotech (NYSE:JNJ) submits its Biologics License Application (BLA) to the FDA seeking approval of sirukumab for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA), a chronic systemic inflammatory condition affecting ~1.5M Americans.
- The data supporting the filing was generated in five late-stage studies in its SIRROUND program.
- Sirukumab is being co-developed by GlaxoSmithKline (GSK) and Janssen Biologics in a partnership that began in late 2011. It is a human monoclonal IgG kappa antibody that binds to interleukin-6 (IL-6), a cytokine that plays a key role in autoimmune conditions. The companies expect it to be a blockbuster generating peak sales of $1B+. It is also being investigated for the treatment of major depressive disorder, lupus nephritis, systemic lupus erythematosus, asthma and polymyalgia rheumatica.