A panel of the U.S. Food and Drug Administration Tuesday recommended an expanded approval of Abbott Laboratories' (ABT) blockbuster rheumatoid arthritis drug Humira to treat ulcerative colitis - a type of inflammatory bowel disease.
The FDA's Gastrointestinal Drugs Advisory Committee comprising outside experts voted 15 - 2, backing Humira's use in patients with moderate to severe ulcerative colitis who failed standard treatments. The FDA panel found that the benefits of Humira outweighed its risks. Nonetheless, the panel asked Abbott to conduct more studies upon Humira's approval. The FDA normally consider the recommendations of the panel though it is not bound to do so.
If approved for ulcerative colitis, Humira will compete with Johnson & Johnson's Remicade (JNJ). An FDA approval will also place Humira as the first biologic drug that people could inject themselves to treat ulcerative colitis, as rival drug Remicade requires a doctor to administer it intravenously.
Ulcerative colitis is a form of colitis, a disease of the colon (large intestine), that includes characteristic ulcers. Symptoms of the disease include diarrhea, rectal bleeding, incontinence, fever, and weight loss. In the U.S., about 700,000 people are said to suffer from the disease.
The FDA last November rejected Abbott's application for Humira in ulcerative colitis, asking for further information.
Abbott studied Humira in two trials involving over 1,000 patients with ulcerative colitis. Both the trials showed positive results, with improvement in rates of disease remission compared to a placebo.
Results from the studies showed about 17 to 19 percent of patients treated with Humira achieved disease remission at eight weeks, compared with about 9 percent for those on a placebo. Similar results were shown after one year.
While some outside experts opined that the difference in remission rates between Humira and placebo may not be meaningful, others advocated that even a slight benefit was helpful for those left with fewer treatment options.
Humira is currently approved for six conditions, including rheumatoid arthritis and Crohn's disease, and is also approved for ulcerative colitis in the European Union. In 2011, Abbott recorded Humira sales of about $8.0 billion. Abbott is also studying the drug for other indications including pediatric Crohn's disease.
ABT is trading at $65.73, up 0.02%, on a volume of about 2.8 million shares on the NYSE. In after hours, the stock dropped 0.02%.
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