Xultophy
Metabolic· 1186 cited findings· 2 source documents
Company: Novo Nordisk A S →
What the regulatory reviews say
Xultophy is a drug that received EU regulatory approval in September 2014, following a Marketing Authorisation application submitted on 31 May 2013. A Type II variation was submitted on 1 November 2017. The regulatory procedure number is EMEA/H/C/002647/II/0023.
In terms of efficacy, Xultophy demonstrated a reduction in HbA1c from baseline of -1.16% for liraglutide compared to -0.77% for placebo. The HbA1c treatment difference between liraglutide and placebo was -0.4%. The Hazard Ratio for composite microvascular endpoint was 0.84, and for nephropathy composite was 0.78, indicating a 22% reduction in the risk of nephropathy events. The nephropathy event rate for liraglutide was 5.7% compared to 7.2% for placebo. The relative risk for EAC-confirmed hypoglycaemic episodes (IDeg vs IGlar) was 0.60.
Safety data indicated an overall neoplasm rate of 10.1% for liraglutide versus 9.0% for placebo. Malignant neoplasms were observed at 6.3% for liraglutide and 6.0% for placebo. Pancreatic neoplasms occurred at a rate of 0.3% for liraglutide and 0.1% for placebo, with malignant pancreatic neoplasms event rates of 0.08 events per 100 PYO for liraglutide and 0.03 events per 100 PYO for placebo.
Key figures — cited to the source page
| HbA1c reduction from baseline (liraglutide) | -1.16 | Novo Nordisk A S — Xultophy EMA EPAR variation assessment re, p.41 |
| HbA1c reduction from baseline (placebo) | -0.77 | Novo Nordisk A S — Xultophy EMA EPAR variation assessment re, p.41 |
| Hazard Ratio for composite microvascular endpoint | 0.84 | Novo Nordisk A S — Xultophy EMA EPAR variation assessment re, p.41 |
| Reduction in risk of nephropathy events | 22 | Novo Nordisk A S — Xultophy EMA EPAR variation assessment re, p.41 |
| Overall neoplasms (liraglutide) | 10.1 | Novo Nordisk A S — Xultophy EMA EPAR variation assessment re, p.47 |
| Overall neoplasms (placebo) | 9.0 | Novo Nordisk A S — Xultophy EMA EPAR variation assessment re, p.47 |
| Malignant pancreatic neoplasms event rate (liraglutide) | 0.08 | Novo Nordisk A S — Xultophy EMA EPAR variation assessment re, p.48 |
| Xultophy EU regulatory approval date | September 2014 | Novo Nordisk A S — Xultophy EMA EPAR variation assessment re, p.6 |
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.