Reuters: Regulatory News: Abbott may need more Humira studies, FDA staff say

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Abbott may need more Humira studies, FDA staff say Aug 24th 2012, 12:26 WASHINGTON | Fri Aug 24, 2012 8:26am EDT WASHINGTON Aug 24 (Reuters) - U.S. drug reviewers said Abbott Laboratories Inc might need to conduct additional trials of Humira to prove the blockbuster drug helps patients with ulcerative colitis. Staff from U.S. Food and Drug Administration questioned whether Humira had a real benefit for people with the inflammatory bowel disease and who had already failed other treatments. The FDA review comes ahead of an advisory panel, which will vote on whether to recommend the drug on Tuesday. Humira, one of the world's top-selling drugs, is already approved for six conditions, including arthritis, but the company is hoping to expand its use to ulcerative colitis, a progressive disease that causes ulcers in the colon.

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