HORSHAM, PA – A new treatment is available for adults with moderate to severe ulcerative colitis.
The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection, which works by blocking tumor necrosis factor (TNF). Simponi is marketed by Janssen Biotech Inc.
Previously approved to treat rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, Simponi is approved to treat adults with moderate to severe ulcerative colitis that is resistant to prior treatment or requires continuous steroid therapy.
Safety and effectiveness of Simponi used to treat ulcerative colitis were established in two clinical studies. Evaluations of patients included measures of stool frequency, rectal bleeding, endoscopic findings and a physician’s overall assessment.
The most common side effects in patients treated with Simponi are upper respiratory infection and redness at the site of injection. Patients treated with the drug are at increased risk of also developing serious infections, invasive fungal infections, reactivation of Hepatitis B infection, lymphoma, heart failure, nervous system disorders and allergic reactions.