FDA has approved Wegovy, the weekly semaglutide treatment for obesity from Novo Nordisk (CPH:NOVO-B).
The agency approved the use of semaglutide for type 2 diabetes in 2017. FDA approved an oral formulation for diabetes in 2019.
Semaglutide is a glucagon-like peptide (GLP-1) receptor agonist (RA) that continues to find wider use.
In clinical trials, Novo Nordisk people led to an average weight loss of 15% to 18% of body weight over 68 weeks in patients with obesity without diabetes.
In a clinical trial published in JAMA and The New England Journal of Medicine, semaglutide tripled weight loss for participants who received lifestyle management coaching.
Novo Nordisk continues to research new potential uses of the drug. It has launched clinical trials to test its use for conditions ranging from atherosclerosis to Alzheimer’s and Parkinson’s disease. A posthoc analysis involving three cardiovascular clinical trials found that participants receiving semaglutide or a related drug known as liraglutide had an approximately 50% lower incidence of dementia.
Novo Nordisk is also filing paperwork to expand the label for semaglutide to support a 2.0 mg weekly dose for diabetes. FDA delayed that application in March after it issued a refusal to file letter.
Lilly is currently developing a dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 RA known as tirzepatide that bested semaglutide as a diabetes treatment in clinical trials. Lilly is also running clinical trials for tirzepatide to test its potential in weight management and conditions, including non-alcoholic steatohepatitis and cardiovascular disease.