NOVO — Wegovy FDA Review (NDA/BLA 215256, 2026)
NOVO · 2026 · FDA Review (Drugs@FDA)
Report summary
The FDA approved Novo Nordisk's Wegovy (semaglutide) injection and tablets for multiple indications, including cardiovascular risk reduction, long-term weight management in adults and pediatric patients, and treatment of noncirrhotic MASH with liver fibrosis. Dosage guidelines are provided. The report details contraindications, warnings (e.g., thyroid C-cell tumors, pancreatitis, hypoglycemia), and adverse reactions observed in clinical trials, such as gastrointestinal issues, kidney injury, and heart rate increases. Pharmacokinetic data, immunogenicity, and nonclinical toxicology are discussed. Efficacy studies demonstrate significant weight loss, MACE reduction, and improvements in MASH. Recent approvals include a new manual prefilled syringe (mPFS) presentation, with CMC and clinical pharmacology reviews confirming comparability to existing auto-injectors. Labeling and human factors studies addressed potential use errors for the mPFS.
Key findings — cited to the page
| WEGOVY injection maintenance dosage (noncirrhotic MASH) | 2.4 mg once weekly | WEGOVY · p.14 |
| WEGOVY injection minimum maintenance dosage (noncirrhotic MASH) | 1.7 mg once weekly | WEGOVY · p.14 |
| Application Number | 215256Orig1s031 | · p.1 |
| Generic or Proper Name | semaglutide | · p.1 |
| Sponsor | Novo Nordisk Inc. | · p.1 |
| Approval Date | May 5, 2026 | · p.1 |
| Trade Name | WEGOVY | · p.1 |
| Indication | 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. | WEGOVY · p.1 |
| Indication | 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 weight related comorbid condition. | WEGOVY · p.1 |
| Indication | 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. | WEGOVY · p.1 |
| Approval Type | accelerated approval | WEGOVY · p.2 |
| Maintenance dosage of WEGOVY tablets | 25 mg orally once daily | WEGOVY · United States · p.10 |
Source: NOVO ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →