Panel Supports Expanding Use of the Abbott Drug Humira

Abbott Laboratories won support from a federal drug panel on Tuesday for wider use of its popular rheumatoid arthritis drug, Humira, for treating 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 the disease, ulcerative colitis.

The F.D.A. usually follows panel recommendations, although it is not required to do so. 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, is already approved for six conditions, including rheumatoid arthritis and Crohn’s disease.

Abbott hopes to expand its use to people with moderate to severe ulcerative colitis, a chronic disease that causes ulcers in the colon and affects about 700,000 Americans. The drug would be used only in people who had not had success with other medicines for the condition.

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.

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

The F.D.A. rejected Abbott’s first application for Humira in treating ulcerative colitis last November, saying results from clinical trials did not show conclusively that the drug helped stop the symptoms of the disease, which include diarrhea, rectal bleeding, incontinence, abdominal pain, fever, fatigue and weight loss.

Some outside advisers also questioned whether a difference of less than 10 percent between Humira and a placebo was meaningful, based on data from clinical trials. But others said even a modest benefit was helpful for those with few other options.

Abbott has said new uses for Humira could add more than $1 billion in sales, though it did not specify projections for ulcerative colitis. Humira was already approved for ulcerative colitis in the European Union, and Abbott is testing it in other conditions such as pediatric Crohn’s disease.

Stock in Abbott, which is based in Abbot Park, Ill., rose 1 cent, to $65.73 a share.



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