U.S. FDA panel: Novo Nordisk's
liraglutide safe, effective for obesity
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[September 12, 2014] By
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 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
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."
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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
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
(Additional reporting Toni Clarke; Editing by David Gregorio and Dan
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