Janssen Biotech has announced the FDA approval of Simponi (golimumab) to treat moderately to severely active ulcerative colitis (UC) in adult patients with corticosteroid dependence or an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine.
The first and only subcutaneously administered anti-tumor necrosis factor (TNF)-alpha therapy is approved to induce and maintain clinical response and improve endoscopic appearance of the mucosa during induction.
Additionally, the product is indicated to induce clinical remission and achieve and sustain clinical remission in induction responders.
A 200mg subcutaneous injection of Simponi should be administered at week zero, followed by 100mg at week two and then 100mg every four weeks, thereafter to treat UC.
Janssen Biotech medical affairs vice president Cindy Guzzo said, "The approval of SIMPONI for the treatment of UC is a notable milestone for adults living with this chronic, devastating disease for which there is no cure."
The FDA also approved Simponi for the treatment of moderately to severely active rheumatoid arthritis (RA) with the medicine methotrexate, active psoriatic arthritis alone or with the medicine methotrexate and active ankylosing spondylitis.
