NOVO — Ozempic FDA Review (NDA/BLA 209637, 2026)
NOVO · 2026 · FDA Review (Drugs@FDA)
Report summary
The FDA approved Novo Nordisk's Ozempic (semaglutide) injection for type 2 diabetes and cardiovascular risk reduction. Key safety information includes a boxed warning for thyroid C-cell tumors and new warnings about pulmonary aspiration during general anesthesia. Clinical trials demonstrated Ozempic's efficacy in reducing HbA1c and body weight, with common adverse reactions being gastrointestinal issues and hypoglycemia. The SUSTAIN 6 trial specifically showed a reduction in major adverse cardiovascular events (MACE). The report also details regulatory information, including storage, administration, and labeling changes for the GLP-1 receptor agonist class regarding aspiration risk.
Key findings — cited to the page
| Percentage of male patients in placebo-controlled trials | 55 % | · p.15 |
| Mean age of patients in placebo-controlled trials | 56 years | · p.15 |
| Mean duration of exposure to OZEMPIC in placebo-controlled trials | 32.9 weeks | · p.15 |
| Percentage of patients 75 years or older in placebo-controlled trials | 3.4 % | · p.15 |
| Approval Date | November 1, 2024 | OZEMPIC (semaglutide) · p.1 |
| New safety information notification date | September 6, 2024 | glucagon-like peptide-1 receptor agonist (GLP-1 RA) products · p.4 |
| Labeling revision date for Pulmonary Aspiration During General Anesthesia or Deep Sedation | 11/2024 | OZEMPIC (semaglutide) · p.10 |
| Indication | as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. | OZEMPIC (semaglutide) · p.1 |
| Indication | to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. | OZEMPIC (semaglutide) · p.1 |
| Number of patients exposed to OZEMPIC in placebo-controlled trials | 521 | · p.15 |
| Supplemental New Drug Application (sNDA) received date | October 4, 2024 | Ozempic (semaglutide) injection · p.4 |
| Percentage of White patients in placebo-controlled trials | 71 % | · p.15 |
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 →