FDA Wary Of Wider Use For Abbott's Humira

Law360, New York (August 24, 2012, 3:26 PM EDT) -- Abbott Laboratories could be facing another setback in efforts to win approval for wider use of blockbuster biologic medicine Humira after U.S. Food and Drug Administration researchers on Friday questioned the treatment’s benefits for an intestinal disorder and said more study might be needed.

The news came in advance of an FDA advisory committee meeting Tuesday, when panelists will consider whether to recommend allowing Humira for adults with ulcerative colitis, which affects as many as 700,000 Americans.

A pair of clinical trials provide only “moderate evidence...
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