WEGOVY HD (NDA215256)- (7.2MG/0.75ML (7.2MG/0.75ML))
SEMAGLUTIDE
NOVO
7.2MG/0.75ML (7.2MG/0.75ML)
Yes
No
2041-Feb-17
Expired
None
None
None
No
WEGOVY is a glucagon-like peptide-1 (GLP-1) receptor agonist. WEGOVY injection is indicated in combination with a reduced calorie diet and increased physical activity: To reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CV disease and either obesity or overweight. To reduce excess body weight and maintain weight reduction long term in: Adults and pediatric patients aged 12 years and older with obesity , Adults with overweight in the presence of at least one weightrelated comorbid condition. For the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) in adults. This indication is approved under accelerated approval based on improvement of MASH and fibrosis. Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial.
