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

Read time: 1 mins
Last updated:18th Jul 2012
Published:18th Jul 2012
Source: Pharmawand
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.

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