Simponi(Janssen Biotech) filed at FDA and EMA for Ulcerative Colitis treatment

Janssen Biotech and Janssen Biologics have requested the FDAand European Medicines Agency to approve Simponi(golimumab) a treatment for "adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy." Simponi ,a once-monthly subcutaneously administered drug , received approvals in the United States, Europe and Canada in 2009 for the treatment of moderately to severely-active rheumatoid arthritis and, in combination with methotrexate, for active psoriatic arthritis and for active ankylosing spondylitis.