FDA approves drug for ulcerative colitis
WASHINGTON, D.C.; May 15, 2013 (WPVI) -- The Food & Drug Administration today approved the biologic drug Simponi for moderate to severe cases of ulcerative colitis.
That is an chronic inflammatory bowel disease which affects 700,000 Americans.
Simponi, developed by Janssen Biotech, of Horsham, Pa., is the first and only drug of its type to demonstrate both an improvement in symptoms, and the appearance of the intestinal lining as seen through an endoscope.
Dr. William Sandborn, the lead investigator on Simponi studies, says this approval is important, because it brings a new option to sufferers of a disease for which there have been few options.
Simponi is already approved for rheumatoid arthritis.
It will be given 200 milligrams at a time once every 2 weeksfor 2 doses, then 100 milligrams every 4 weeks after that.
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