8/24/2012 10:58:46 AM
Abbott Laboratories (ABT)’ rheumatoid arthritis drug Humira, the company’s top-selling product, may not be effective in treating ulcerative colitis in patients who don’t respond to conventional therapies, U.S. regulators said. While two trials on Humira’s use for moderate to severe ulcerative colitis met the studies’ goals, Food and Drug Administration staff in a report today questioned the “clinical meaningfulness” of a difference between patients’ reaction to the drug and a placebo. The staff also said limitations to the studies “introduced uncertainty” to the results.
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