UPDATE 2-US FDA advisers back wider use of Abbott's Humira
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Tue Aug 28, 2012 3:54pm EDT
* Recommend drug for ulcerative colitis
* FDA first rejected Humira for this use last November
* Advisers say patients need more options
By Anna Yukhananov
WASHINGTON, Aug 28 (Reuters) - Abbott Laboratories Inc won a U.S. panel's support o n T uesday for wider use of its blockbuster 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 ulcerative colitis. The drug is already approved for six other conditions.
The FDA 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 only be used in people who have 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.
"Especially for my patients who live many miles away, I would like to have this drug in my clinical armamentarium," said panel member Dr. Amandeep Shergill, assistant clinical professor in gastroenterology at the University of California in San Francisco.
However, 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.
INITIAL REJECTION
Ahead of the advisory meeting, FDA reviewers suggested the company should do further clinical trials prior to approval to prove the drug actually helped patients.
The FDA rejected Abbott's first application for Humira in ulcerative colitis last November, saying results from clinical trials did not conclusively show 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.
"Although the absolute delta is small, which is disappointing, it's still a viable option," said panel member Dr. Marc Wishingrad, who focuses on digestive diseases at a private practice and at the University of California in Los Angeles.
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 also testing it in other conditions such as pediatric Crohn's disease.
The panel also voted that Abbott has not found the appropriate dose for Humira in this indication, according to Bloomberg.
