FDA approves J&J's Simponi for ulcerative colitis

Chronic condition affects more than 600,000 Americans

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating ulcerative colitis, the agency said Wednesday.

The FDA announced the approval of Simponi (golimumab) for adults with moderate to severe forms of the condition, a chronic disease that affects more than 600,000 Americans. The disease causes inflammation and ulcers in the inner lining of the large intestine and can lead to abdominal discomfort, gastrointestinal bleeding, pus and diarrhea. The drug — part of a class known as tumor necrosis factor inhibitors, so named because they work by suppressing TNF, a major reason in causing inflammatory and autoimmune disorders — is made by J&J subsidiary Janssen Ortho Biotech, based in Horsham, Pa.

The drug is already approved to treat rheumatoid arthritis.


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