Novo Nordisk’s Liraglutide Gets Panel Nod For Weight Management
Advisory committee members are generally comfortable with use of the GLP-1 receptor agonist in the first-line setting, suggesting that a second-line treatment restriction in diabetes could be lifted.
You may also be interested in...
As a reviewer, team leader and deputy director in the Division of Metabolism and Endocrinology Products, Colman spearheaded the agency’s policy development on weight-management products.
The biotech finally gleaned an FDA approval for its obesity pill Contrave and now faces the hurdle of commercialization, but plans to profit by the lessons from its competitors’ missteps.
If cardiovascular studies are required for non-cardiac drugs, they should be focused on specific signals of heart-related concern that may not include ischemic events, advisory committee cardiologists say during review of Novo Nordisk’s Saxenda for obesity.