Boehringer Ingelheim — Glyxambi EMA EPAR public assessment report (EMEA/H/C/003833, 2016)
Boehringer Ingelheim · 2016 · EMA EPAR public assessment report
Report summary
This EMA EPAR summarizes the 2016 marketing authorization assessment for Glyxambi (empagliflozin/linagliptin) for type 2 diabetes. The report details the quality, pharmaceutical development, and non-clinical assessment of the fixed-dose combination. Pharmacokinetic and pharmacodynamic studies confirmed bioequivalence and no significant interactions between components. Clinical efficacy, demonstrated in Phase III trials, showed significant reductions in HbA1c, fasting plasma glucose, and body weight, primarily with empagliflozin. The safety profile was consistent with individual components, with low rates of adverse events and no increased risk compared to monotherapy. Overall, Glyxambi demonstrated favorable efficacy and safety for type 2 diabetes.
Key findings — cited to the page
| Linagliptin human exposure multiple for stomach irritation | 100 times | Cynomolgus monkeys · p.27 |
| Empagliflozin Daphnia sp. Reproduction Test NOEC | 100 mg/L | · p.31 |
| Linagliptin Daphnia sp. Reproduction Test NOEC | 3.2 mg/L | · p.32 |
| Application submission date | 8 October 2015 | Glyxambi · EU · p.7 |
| Volume depletion | 0.9 % | study 1275.9 · p.73 |
| Bone fracture | 0.8 % | study 1275.10 · p.74 |
| Malignancy | 0 | study 1275.9 · p.73 |
| Volume depletion | 0.9 % | study 1275.10 · p.74 |
| Volume depletion | 0.8 % | study 1275.10 · p.74 |
| Malignancy | 0 | study 1275.10 · p.74 |
| Malignancy | 0.9 % | study 1275.9 · p.73 |
| Volume depletion | 0 | study 1275.10 · p.74 |
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 →