Victoza(Liraglutide)
Metabolic· 3204 cited findings· 1 source document
Company: NOVO NORDISK INC
What the regulatory reviews say
Victoza (Liraglutide) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is also indicated to reduce the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes mellitus and established cardiovascular disease. The sNDA for this indication was submitted on October 25, 2016, and approved on August 25, 2017.
In the US subgroup, the observed hazard ratio for MACE was 1.026 (95% CI: 0.84-1.25). For cardiovascular death, the hazard ratio was 1.04 (95% CI: 0.75, 1.46), and for all-cause death, it was 1.09 (95% CI: 0.84, 1.40). Non-cardiovascular deaths were 3.5% for Victoza and 3.6% for placebo. EAC-confirmed pancreatitis subjects were 0.4% for Victoza and 0.5% for placebo, with event rates of 0.11 and 0.19 per 100 PY, respectively.
Key figures — cited to the source page
| MACE HR (US) | 1.03 | Victoza FDA Review, p.110 |
| MACE 95% CI (US) | 0.84, 1.25 | Victoza FDA Review, p.110 |
| CV DEATH HR (US) | 1.04 | Victoza FDA Review, p.110 |
| ALL-CAUSE DEATH HR (US) | 1.09 | Victoza FDA Review, p.110 |
| Non-cardiovascular deaths (Victoza) | 3.5 | Victoza FDA Review, p.38 |
| EAC-confirmed pancreatitis subjects (%) | 0.4 | Victoza FDA Review, p.138 |
| Approval Date | August 25, 2017 | Victoza FDA Review, p.1 |
| Indication | to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease | Victoza FDA Review, p.1 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.