FDA advisers OK Humira to treat ulcerative colitis

Abbott Laboratories Inc. won a U.S. panel’s support Tuesday for wider use of its blockbuster Humira drug in a type of inflammatory bowel disease.

A panel of outside advisers to the Food and Drug Administration voted 15 to 2 that the benefits of Humira outweighed its risks in treating ulcerative colitis. The drug is approved for six other conditions.

The FDA usually follows panel recommendations, although it is not required to, and a final decision is expected by the end of the year.

Humira, one of the world’s top-selling drugs with projected sales of $9 billion this year. Its uses include treatment of rheumatoid arthritis and Crohn’s disease. Abbott hopes to expand that to people with moderate to severe ulcerative colitis, a chronic disease that causes ulcers in the colon and affects about 700,000 Americans.

If approved for ulcerative colitis, Humira would be the first biologic drug that people could inject themselves, Abbott said. Johnson & Johnson’s Remicade, a competing treatment that works in a similar way to Humira, must be given intravenously in the hospital.

Some doctors who voted in favor of the drug said the self-injectable option would be helpful.

“Especially for my patients who live many miles away, I would like to have this drug in my clinical armamentarium,” said Dr. Amandeep Shergill, assistant clinical professor in gastroenterology at the University of California in San Francisco and a panel member.

However, most panel members also called on the company to do more studies after the drug is approved, especially whether it should be given in a higher dose.

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chicagotribune.com