A Food and Drug Administration (FDA) Advisory Committee has voted in favor of recommending liraglutide for chronic weight management in individuals with obesity or who are overweight with at least one weight-related comorbidity.
The decision by the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA was based on data from clinical trials of liraglutide, including the Phase 3 SCALE trial of over 5,000 patients with obesity (BMI ≥30kg/m2), or who are overweight (BMI ≥27kg/m2) with comorbidities. The clinical trial and post-marketing experience with liraglutide for diabetes mellitus with doses up to 1.8mg/day was also evaluated.
The panel voted 14-1 that the overall benefit-risk assessment of liraglutide was favorable and supports approval in individuals with obesity or who are overweight in the presence of at least one weight-related comorbidity.
The New Drug Application (NDA) for liraglutide 3mg, an investigational once-daily glucagon-like peptide-1 (GLP-1) analogue for weight management, was submitted to the FDA in December 2013. The Prescription Drug User Fee Act (PDUFA) date for completion of the FDA review of the NDA is October 20, 2014. If approved, the drug will be sold under the name Saxenda.
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