Abbott Laboratories : Abbott Bid For US Approval Of New Use For Humira Is Delayed
05/22/2012| 09:21am US/Eastern
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By Peter Loftus
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Abbott Laboratories (ABT) has encountered a delay in its bid for U.S. regulatory approval to expand the uses of its blockbuster anti-inflammatory drug Humira to include treatment of the bowel disease ulcerative colitis.
Abbott received a "complete response letter" from the U.S. Food and Drug Administration in late 2011 regarding Abbott's application to market Humira for colitis, spokeswoman Elizabeth Hoff said Monday. The FDA sends such letters when a drug application isn't yet ready for approval.
The Abbott Park, Ill., company has provided additional information and continues to have a dialogue with the FDA, Hoff said.
Abbott expects an agency decision by the end of this year, she said. She declined to provide contents of the complete response letter.
Abbott filed for regulatory approval of Humira to treat ulcerative colitis in the U.S. and Europe in early 2011. The European Commission approved the new use in April.
The regulatory applications were based on clinical data showing that Humira improved rates of disease remission versus a placebo in people with colitis, an inflammatory bowel disease that causes pain, diarrhea and other symptoms.
Humira is currently approved in the U.S. to treat rheumatoid arthritis and several other inflammatory conditions. Abbott recorded $7.9 billion in Humira sales for 2011.
-By Peter Loftus, Dow Jones Newswires; +1-215-982-5581; peter.loftus@dowjones.com
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