Merck & Co., Inc. — Segluromet EMA EPAR variation assessment report (EMEA/H/C/004314, 2018)
Merck & Co., Inc. · 2018 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the EMA's assessment of Merck's application to extend the indication for Segluromet and Steglatro, based on the VERTIS CV study. This large, randomized, placebo-controlled trial (8,238 patients with type 2 diabetes and established cardiovascular disease) evaluated ertugliflozin's cardiovascular safety and efficacy. The study demonstrated ertugliflozin's non-inferiority for major adverse cardiovascular events (MACE) and a significant reduction in hospitalization for heart failure (HHF). While not meeting superiority for the composite of CV death or HHF, it showed beneficial effects on HbA1c, fasting plasma glucose, body weight, and blood pressure, including in patients with chronic kidney disease. Safety findings indicated higher incidences of genital mycotic infections, urinary tract infections, and ketoacidosis with ertugliflozin, but similar rates for serious adverse events, amputations, fractures, and renal adverse events compared to placebo. The report also details adverse events across various subgroups and updates to product information.
Key findings — cited to the page
| HHF HR for all ertugliflozin vs placebo in HF with preserved EF >45% | 0.70 | · p.42 |
| subjects with preserved EF > 40% | 4464 subjects | · p.30 |
| subjects with HF and preserved EF > 40% | 1197 subjects | · p.31 |
| HHF 95% CI for all ertugliflozin vs placebo in HF with preserved EF >45% | 0.391 to 1.255 | · p.42 |
| subjects with HF and preserved EF > 40% | 61.1 % | · p.31 |
| subjects with preserved EF > 40% | 54.1 % | · p.30 |
| Procedure Number | EMEA/H/C/WS1953 | · p.1 |
| Incidence of Anaemia (%) (placebo) | 3.3 % | VERTIS CV · p.66 |
| Product-specific application number for Steglatro | EMEA/H/C/004315/WS1953/0013 | Steglatro · p.1 |
| Incidence of Anaemia (placebo) | 90 | VERTIS CV · p.66 |
| Incidence of Fall (placebo) | 45 | VERTIS CV · p.66 |
| major protocol deviations in ertugliflozin 5 mg group | 13.8 % | · p.29 |
Source: Merck & Co., Inc. ↗ · 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 →