Boehringer Ingelheim — Synjardy EMA EPAR public assessment report (EMEA/H/C/003770, 2015)
Boehringer Ingelheim · 2015 · EMA EPAR public assessment report
Report summary
The EMA granted Marketing Authorisation for Synjardy (empagliflozin/metformin) on March 26, 2015, following Boehringer Ingelheim's application. The assessment confirmed the product's quality, manufacturing, and stability. Non-clinical studies demonstrated synergistic glucose reduction and acceptable toxicology. Pharmacokinetic analysis detailed drug absorption, distribution, metabolism, and excretion, including bioequivalence for the fixed-dose combination. Clinical trials showed empagliflozin's dose-dependent increase in urinary glucose excretion and significant reductions in HbA1c, FPG, and body weight, both as monotherapy and in combination with metformin. While generally effective, especially in reducing HbA1c and FPG, efficacy was reduced in elderly patients or those with impaired renal function. Safety concerns included increased genital infections and an initial decline in eGFR, which later stabilized. Other adverse events included increased hematocrit and cholesterol. Risk minimization measures were outlined.
Key findings — cited to the page
| Metformin NOEC (Daphnia sp. Reproduction Test) | 17 mg/L | · p.21 |
| Empagliflozin NOEC (Daphnia sp. Reproduction Test) | ≥ 100 mg/L | · p.23 |
| Metformin LC100 (Daphnia sp. Reproduction Test) | 55 mg/L | · p.22 |
| Metformin LC50 (Daphnia sp. Reproduction Test) | 38 mg/L | · p.21 |
| Urinary glucose excretion increase with empagliflozin 25 mg | 78 g/day | empagliflozin · p.7 |
| Marketing Authorisation Application submission date | 3 July 2014 | Synjardy · Europe · p.5 |
| CHMP positive opinion date | 26 March 2015 | Synjardy · Europe · p.6 |
| Empagliflozin (Jardiance) EU authorisation date | May 2014 | Jardiance · EU · p.7 |
| body weight gain | 16.2 % higher | · p.14 |
| Metformin dose causing developmental retardation in rats | 1000 mg/kg | · p.20 |
| body weight gain | 7.3 % higher | · p.14 |
| HbA1c reduction | -3.32 % | · p.14 |
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 →