Boehringer Ingelheim — Jardiance EMA EPAR variation assessment report (EMEA/H/C/002677, 2014)
Boehringer Ingelheim · 2014 · EMA EPAR variation assessment report
Report summary
This report summarizes the CHMP's assessment of Boehringer Ingelheim's application to extend Jardiance (empagliflozin) indication to children aged 10+ with type 2 diabetes. The application relies on the DINAMO (1218-0091) study, which evaluated empagliflozin and linagliptin. Empagliflozin demonstrated statistically superior HbA1c reduction compared to placebo at 26 weeks. While linagliptin did not meet statistical significance, empagliflozin's efficacy was confirmed. Pharmacokinetic modeling compared pediatric and adult data. Safety profiles were generally comparable to placebo, with increased hypoglycemia but no new safety concerns. The CHMP concluded a positive benefit-risk balance, recommending approval for the indication extension.
Key findings — cited to the page
| Bodyweight range in population pharmacokinetic analysis | 42.5 to 169 kg | Study 1218-0091 · p.17 |
| Number of subjects in exposure-response analysis | 103 | Study 1218-0091 · p.17 |
| Number of patients randomized to linagliptin | 53 | DINAMO 1281-0091 · p.27 |
| Number of patients randomized to empagliflozin (pooled) | 52 | DINAMO 1281-0091 · p.27 |
| Number of patients randomized to placebo | 53 | DINAMO 1281-0091 · p.27 |
| Percentage of patients <15 years of age | 48.4 % | DINAMO 1281-0091 · p.27 |
| Percentage of patients female | 61.8 % | DINAMO 1281-0091 · p.27 |
| Mean age of patient population | 14.5 years | DINAMO 1281-0091 · p.27 |
| Percentage of patients on metformin only background therapy | 51.0 % | DINAMO 1281-0091 · p.27 |
| Percentage of patients on metformin plus insulin background therapy | 40.1 % | DINAMO 1281-0091 · p.27 |
| Percentage of patients on insulin only background therapy | 3.2 % | DINAMO 1281-0091 · p.27 |
| Median age in population pharmacokinetic analysis | 14.5 years | Study 1218-0091 · p.17 |
Source: Boehringer Ingelheim ↗ · 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 →