Abbott Laboratories (ABT:US)’ 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.
The disease is treated with generic drugs that reduce inflammation or moderate the immune system. Patients who fail those treatments may be given Johnson & Johnson (JNJ:US)’s Remicade, according to the NIH. Remicade, also used for arthritis, sold $5.49 billion last year. Humira sold $7.93 billion.
Abbott gained less than 1 percent to $61.99 at 4 p.m. New York time. The Humira delay was reported earlier by the Wall Street Journal.
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