FDA Delays Abbott Laboratories's New Use for Top Drug Humira

Published: May 24, 2012

Abbott Laboratories (ABT) (ABT)’ bid to expand use of its best-selling arthritis treatment Humira to ulcerative colitis patients is being delayed by U.S. regulators. “We did receive a complete response letter several months ago and have provided additional information to the” Food and Drug Administration, Elizabeth Hoff, a spokeswoman for the Abbott Park, Illinois-based company, said in an e-mail today. “We’re anticipating a decision by the end of the year.” Ulcerative colitis is an inflammation of the large intestine and rectum caused by unknown immune system problems, according to the National Institutes of Health’s website. The condition can lead to abdominal pain, diarrhea, bloody stool and weight loss. About 500,000 people in the U.S. have the disease, according to the Crohn’s & Colitis Foundation of America.

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