Obesity drug to update label with CV safety information

The FDA approved an updated label for Saxenda to include data showing that the medication does not increase the risk for major cardiovascular events, according to a press release from Novo Nordisk.

The active ingredient in Saxenda — the GLP-1 receptor agonist liraglutide — is the same agent used as the diabetes medication Victoza. Dosing for Saxenda is 3 mg, whereas dosing for Victoza is 1.8 mg.

Last year, the FDA approved an expanded indication for Victoza to include language in the prescribing information that the drug can reduce risks for major adverse CV events, myocardial infarction, stroke and CVD in adults with type 2 diabetes and established CVD.

Both label decisions were based on results from the LEADER trial, which demonstrated a 13% reduced risk for a three-component endpoint of CV death, nonfatal MI and nonfatal stroke with liraglutide 1.8 mg compared with placebo (P = .01), according to the company.

“Obesity is a real disease affecting real people who deserve real care,” W. Timothy Garvey, MD, the Butterworth Professor and Chair in the department of nutrition sciences at the University of Alabama at Birmingham and director of the UAB Diabetes Research Center, said in the release. “People with obesity often do try hard to lose weight on their own, but metabolic and hormonal responses affect the ability to maintain weight loss. That’s why it’s paramount that we continue to develop treatment options that address critical aspects of chronic weight management and the various health factors that contribute to this disease.” – by Jill Rollet

Disclosure: Garvey reports he is on the advisory board of the American Medical Group Association, Alexion, Janssen, Merck and Novo Nordisk, and receives research funding from AstraZeneca, Eisai, Elcelyx, Lexicon, Merck, Novo Nordisk, Pfizer, Sanofi and Weight Watchers.

The FDA approved an updated label for Saxenda to include data showing that the medication does not increase the risk for major cardiovascular events, according to a press release from Novo Nordisk.

The active ingredient in Saxenda — the GLP-1 receptor agonist liraglutide — is the same agent used as the diabetes medication Victoza. Dosing for Saxenda is 3 mg, whereas dosing for Victoza is 1.8 mg.

Last year, the FDA approved an expanded indication for Victoza to include language in the prescribing information that the drug can reduce risks for major adverse CV events, myocardial infarction, stroke and CVD in adults with type 2 diabetes and established CVD.

Both label decisions were based on results from the LEADER trial, which demonstrated a 13% reduced risk for a three-component endpoint of CV death, nonfatal MI and nonfatal stroke with liraglutide 1.8 mg compared with placebo (P = .01), according to the company.

“Obesity is a real disease affecting real people who deserve real care,” W. Timothy Garvey, MD, the Butterworth Professor and Chair in the department of nutrition sciences at the University of Alabama at Birmingham and director of the UAB Diabetes Research Center, said in the release. “People with obesity often do try hard to lose weight on their own, but metabolic and hormonal responses affect the ability to maintain weight loss. That’s why it’s paramount that we continue to develop treatment options that address critical aspects of chronic weight management and the various health factors that contribute to this disease.” – by Jill Rollet

Disclosure: Garvey reports he is on the advisory board of the American Medical Group Association, Alexion, Janssen, Merck and Novo Nordisk, and receives research funding from AstraZeneca, Eisai, Elcelyx, Lexicon, Merck, Novo Nordisk, Pfizer, Sanofi and Weight Watchers.