Reuters: Regulatory News: UPDATE 1-U.S. FDA approves J&J's Simponi to treat ulcerative colitis

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UPDATE 1-U.S. FDA approves J&J's Simponi to treat ulcerative colitis May 15th 2013, 21:49 Wed May 15, 2013 5:49pm EDT May 15 (Reuters) - The U.S. Food and Drug Administration has approved Johnson & Johnson's drug Simponi for patients with moderate to severe ulcerative colitis, an inflammatory disease affecting the colon. Simponi is already approved to treat rheumatoid arthritis. Like RA, ulcerative colitis is an auto-immune disease in which the body's immune system attacks its own organs. In the case of ulcerative colitis, inflammation can lead to open sores or ulcers in the lining of the colon, causing stomach pain, gastrointestinal bleeding and diarrhea. The most common side effects of Simponi in clinical trials of patients with ulcerative colitis were upper respiratory infection and redness at the site in which the drug is injected. Patients treated with Simponi, known also as golimumab, are at increased risk of developing serious infections, reactivation of Hepatitis B infection, heart failure and certain nervous system disorders. The drug is marketed by J&J's Janssen Ortho Biotech unit.

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