Simponi Approved for Ulcerative Colitis
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The drug is designed to block tumor necrosis factor, which has a key role in causing abnormal inflammation and immune system responses, the FDA said Wednesday in a news release.
Ulcerative colitis, affecting some 620,000 Americans, causes chronic inflammation and ulcers in the inner lining of the large intestine. Common symptoms include abdominal discomfort, gastrointestinal bleeding and diarrhea.
Simponi was clinically evaluated in two studies involving more than 800 people. The most common side effects reported were upper respiratory infection and redness at the injection site. People treated with the drug are at greater-than-average risk of contracting several types of infection, lymphoma, heart failure, nervous system disorders and allergic reactions, the FDA said.
The drug is marketed by Janssen Ortho Biotech Inc., based in Horsham, Pa.
-- Scott Roberts