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Janssen Requests Approval of Golimumab for Treatment of Ulcerative Colitis
Approximately 700,000 people in the U.S. are affected by UC, a chronic inflammatory bowel disease marked by inflammation and ulceration of the lining (mucosa) of the colon, which may lead to bloody stools, severe diarrhea, and frequent abdominal pain.
The U.S. application is supported by efficacy and safety findings from the Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment (PURSUIT), which included phase III multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of subcutaneous induction and every-4-week maintenance regimens of Simponi in adults with moderate to severe UC.
Simponi is a human monoclonal antibody that targets and neutralizes excess TNF-alpha, a protein that can cause inflammation and damage to bones, cartilage, and tissue when overproduced in the body in response to inflammatory disease. Simponi is approved in 52 countries, including the U.S., for rheumatologic disorders.
More information can be found on the Sacramento Bee's Web site.