FDA committee recommends approval for liraglutide as anti-obesity drug

Liraglutide 3 mg (Saxenda, Novo Nordisk) has been recommended by an FDA Advisory Committee to be approved for use in the treatment of obesity.

Drug Overview: Liraglutide for the treatment of obesity

The panel of experts voted 14 to 1 to support approval for the injectable, once-daily glucagon-like peptide-1 (GLP-1) analogue. They found that overall the efficacy and safety results demonstrated a favorable benefit/risk profile for its use as a treatment option for weight management. If approved liraglutide 3 mg would be indicated for chronic weight management in persons with a body mass index (BMI) >30 kg/m² (obese) or a BMI >27 kg/m² (overweight) in those who have at least 1 weight-related comorbidity.

Mads Krogsgaard Thomsen, who is the executive vice president and chief science officer of Novo Nordisk, commented: “We are pleased with the clear recommendation from the Advisory Committee. We look forward to working with the FDA as they complete their review.”

The basis for the panel’s recommendation were the results from 4 phase 3 clinical trials, including the SCALE clinical trial program, that enrolled more than 5000 subjects who were obese or who were overweight with comorbidities. Over 3000 of the subjects received liraglutide 3 mg. Of those taking the drug for more than a year, 63.5% lost >5% of their body weight versus 26.6% on placebo. Another 32.8% on liraglutide 3 mg lost >10% of their body weight as compared with 10.1% on placebo.

The GLP-1 analogue liraglutide has a 97% similarity to naturally occurring human GLP-1, which is a hormone that is released in response to food intake. Liraglutide 3 mg works by decreasing hunger and increasing feelings of fullness and satiety after a meal, thereby regulating appetite and food intake. It is intended to be used as an adjunct to a reduced-calorie diet and increased physical activity.

Immediate health benefits associated with liraglutide 3 mg include positive effects on appetite, glycemia, and blood pressure. The FDA Advisory Committee also commented on long-term benefits such as improvements in obstructive sleep apnea, mobility, and quality of life.

The new drug application (NDA) for liraglutide was submitted to FDA on December 20, 2013. The completion date for the FDA review of this NDA is October 20, 2014.

If approved, liraglutide 3 mg would become the first injectable drug indicated for weight loss. Liraglutide was initially approved in a 1.2 or 1.8 dose for the treatment of diabetes mellitus under the brand name Victoza in 2010.