Novo Nordisk A S — Xultophy EMA EPAR variation assessment report (EMEA/H/C/002647, 2014)
Novo Nordisk A S · 2014 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes a Type II variation application for Xultophy (insulin degludec/liraglutide) to update its product information with cardiovascular outcome trial (CVOT) data. The LEADER trial demonstrated liraglutide's superiority in reducing major adverse cardiovascular events (MACE), microvascular events, and all-cause death, alongside improved glycemic control and weight reduction. The DEVOTE trial confirmed insulin degludec's non-inferiority to insulin glargine for MACE and its superiority in reducing severe hypoglycemia. Non-clinical data supported liraglutide's anti-inflammatory and plaque-reducing properties. While generally safe, the report notes uncertainties regarding potential increases in pancreatic carcinoma and malignant melanoma with liraglutide. The updated product information incorporates these findings into relevant sections of the Summary of Product Characteristics.
Key findings — cited to the page
| Nephropathy event rate (liraglutide) | 5.7 % | LEADER trial (Trial 3748) · p.41 |
| Retinopathy event rate (placebo) | 2.0 % | LEADER trial (Trial 3748) · p.41 |
| Hazard Ratio for nephropathy composite | 0.78 | LEADER trial (Trial 3748) · p.41 |
| Reduction in risk of nephropathy events | 22 % | LEADER trial (Trial 3748) · p.41 |
| Nephropathy event rate (placebo) | 7.2 % | LEADER trial (Trial 3748) · p.41 |
| Retinopathy event rate (liraglutide) | 2.3 % | LEADER trial (Trial 3748) · p.41 |
| Type II variation submission date | 1 November 2017 | Xultophy · p.4 |
| Xultophy EU regulatory approval date | September 2014 | Xultophy · EU · p.6 |
| Composite microvascular endpoint event rate | 7.6 % | LEADER trial (Trial 3748) · p.41 |
| Composite microvascular endpoint event rate | 8.9 % | LEADER trial (Trial 3748) · p.41 |
| Hazard Ratio for composite microvascular endpoint | 0.84 | LEADER trial (Trial 3748) · p.41 |
| HbA1c reduction from baseline (liraglutide) | -1.16 % | LEADER trial (Trial 3748) · p.41 |
Source: Novo Nordisk A S ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →