FDA Advisory Committee Votes in Favor of Liraglutide Approval for Obesity
Members of the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 14-1 in favor of approving the once-daily human GLP-1 analogue liraglutide for the treatment of obesity. If approved, the agent will be indicated for the chronic weight management in people who are obese (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) and have at least one weight-related comorbidity.
Recommendation Based on Clinical Trial Data
The recommendation was based on data from clinical trials of liraglutide, including the phase 3 SCALE clinical trial program, which involved more than 5,000 overweight and obese patients.
In one of the largest of these phase 3 trials (n=2,590), liraglutide 3 mg in combination with diet and exercise was associated with significantly greater reduction in body mass index at 56 weeks (8% vs. 2.6% with placebo; P<0.0001). In addition, a significantly greater proportion of patients in the liraglutide group achieving a ≥5% reduction in body weight (64% vs. 27%; P<0.0001) or a 10% reduction (33% vs. 10%; P<0.0001) compared with the placebo group. The most common side effects in this study were nausea and diarrhea.
The New Drug Approval for liraglutide was submitted to the FDA on December 20, 2013 and is expected to be reviewed by October 20, 2014.
Liraglutide is administered by subcutaneous injection and is currently approved for the treatment of type 2 diabetes. Clinical trials and post-marketing experience with liraglutide in the treatment diabetes mellitus involved doses of up to 1.8 mg per day; hence, further assessment by the FDA was needed for the new indication given that a 3-mg dose was used in the obesity trials.
September 30, 2014