FDA Approves Wider Humira Use Despite Efficacy Concerns

Law360, New York (September 28, 2012, 8:14 PM EDT) -- The U.S. Food and Drug Administration on Friday announced it had approved Abbott Laboratories Inc.’s blockbuster anti-inflammatory drug Humira to treat the bowel disease ulcerative colitis, despite agency researchers’ previous concerns over the drug’s usefulness in treating the condition.

According to the FDA’s statement, the drug has been approved to treat moderate to severe ulcerative colitis in patients for whom immunosuppressant medicines — the traditional treatment for the condition — have not worked, following two successful Phase III clinical studies.

Colitis, which causes inflammation and ulcers...
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