U.S. FDA panel: Novo Nordisk's liraglutide safe, effective for obesity

[September 12, 2014] By David Morgan

WASHINGTON (Reuters) - Novo Nordisk's drug liraglutide is safe and effective enough to warrant approval for use in chronically obese patients with at least one weight-related health issue, an advisory panel to the U.S. Food and Drug Administration concluded on Thursday.

The panel voted 14 to 1 to recommend the drug, which is already approved to treat diabetes under the brand name Victoza. It would be sold under the name Saxenda if approved for obesity by the FDA. According to analysts, it could generate $1 billion in revenue for the company.

The FDA typically follows the recommendations of its advisory panels. Just before the vote, Novo Nordisk shares rose 1.8 percent to $46.78 in trading on the New York Stock Exchange.

In a study, half of obese patients given a daily 3 mg injection lost at least 5 percent of body weight, while 22 percent lost more than 10 percent. The drug is proposed for use in patients who also have at least one other weight-related condition, such as hypertension.

The lone opposition vote came from Dr. David Kelsen of the Memorial Sloan Kettering Cancer Center, who said the research did not allay concerns about the potential for increased cancer risks. "Until that information is available, there is a risk of uncertainty," he said.

An FDA report released on Tuesday noted an imbalance in the number of breast malignancies among women who took the drug but said the available data neither supports nor denies the potential role of the drug in cancer promotion or progression.

The drug is also associated with higher resting heart rates and gallbladder-related problems.

Some panelists found little reason to worry about elevated risks but agreed that more study would be welcome, given that patients were studied for only 52 weeks.

"Overall, there is a benefit," said Dr. William Hiatt of the University of Colorado School of Medicine. “If you lose weight in this manner, patients can report an improvement in their quality of life and in their physical functioning."

Panel members heard from 20 public witnesses. Two cautioned against recommendation, saying long-term cardiovascular and cancer risks have not been adequately assessed, particularly for blacks and Hispanics, who are vulnerable to obesity.

Others, including some tearful obesity suffers, urged the committee to favor liraglutide in hopes of delivering an effective therapy for people who are unable to control their weight through diet and exercise.

More than one-third of American adults are obese, according to the U.S. Centers for Disease Control and Prevention. Excess weight is a leading cause of heart disease, stroke, diabetes and certain cancers. But safe treatments remain elusive.

If approved, Saxenda would compete with Vivus Inc's Qsymia and Belviq from Arena Pharmaceuticals Inc and Eisai. It would also compete with a new drug from Orexigen Inc that was approved on Wednesday.

(Additional reporting Toni Clarke; Editing by David Gregorio and Dan Grebler)

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