Nine Out Of 10 Lost Weight With Novo Nordisk A/S's Obesity Drug Liraglutide
Published: Nov 05, 2014
November 4, 2014
By Jessica Wilson, BioSpace.com Breaking News Staff
Danish drugmaker Novo Nordisk today announced results from its Phase 3a study of the drug liraglutide for the treatment of obesity. A high percentage of trial participants, specifically 92%, lost weight with a liraglutide 3 mg treatment, in combination with diet and exercise, compared with 65% on the placebo treatment in the 56-week study. In addition, patients treated with liraglutide experienced weight loss of 9.2% compared with a 3.5% reduction in the placebo group.
The results of the study, entitled SCALE, were presented at ObesityWeek 2014, the 2nd Annual Congress of The American Society for Metabolic and Bariatric Surgery and The Obesity Society. SCALE Researchers also found that patients who received liraglutide experienced improvements in health-related quality of life (HRQoL) as measured by three different questionnaires.
“Obesity is more than a disease of excess weight,” Ken Fujioka of the Department of Nutrition and Metabolic Research at the Scripps Clinic and a SCALE clinical trial investigator was quoted as saying in the press release. “We know that people with obesity may experience increased physical and mental health problems, as well as a reduced quality of life. It is encouraging to see data suggesting that the weight loss benefits of liraglutide 3 mg are associated with improved health-related quality of life for people with obesity.”
A harbinger of these results occurred in Sept. 2014 when an advisory panel to the U.S. Food and Drug Administration (FDA) recommended, by a vote of 14 to 1, that liraglutide was safe and effective enough to warrant approval for use in chronically obese patients. Though the FDA is not bound by the advisory panel’s recommendations, the agency does usually follow them.
Liraglutide, which is currently marketed under the name Victoza, is approved for the treatment of diabetes. At the time of the advisory panel’s announcement, Reuters reported that Novo would sell liraglutide “under the name Saxenda if approved for obesity by the FDA.” Reuters also claimed that, “according to analysts, it could generate $1 billion in revenue for the company.”
The dissenting panelist, David Kelsen of the Memorial Sloan-Kettering Cancer Center, claimed that the data did not put to rest his concerns about increased cancer rates. “Until that information is available, there is a risk of uncertainty,” he was quoted as saying by Reuters. The FDA released a report at that time that “noted an imbalance in the number of breast malignancies among women who took the drug,” but concluded the data neither supports nor denies the potential cancer risk.