Boehringer Ingelheim — Jardiance EMA EPAR public assessment report (EMEA/H/C/002677, 2014)
Boehringer Ingelheim · 2014 · EMA EPAR public assessment report
Report summary
The EMA's CHMP assessed Jardiance (empagliflozin) for type 2 diabetes. This selective SGLT2 inhibitor demonstrated significant reductions in HbA1c, body weight, and blood pressure across various patient populations and treatment regimens, including monotherapy and add-on therapies. Preclinical studies showed a favorable safety profile at high doses, with some species differences in pharmacokinetics. Clinical trials confirmed efficacy, even in mild to moderate renal impairment, though it diminished in severe cases and elderly patients. Key safety concerns include increased risks of genital and urinary tract infections, volume depletion, and potential renal function decline. While overall adverse event rates were similar to comparators, hypoglycemia increased when combined with insulin or sulfonylurea. Despite these safety considerations, the CHMP recommended marketing authorization, acknowledging its positive benefit-risk balance.
Key findings — cited to the page
| NOEC for Daphnia sp. Reproduction Test | 100 mg/L | · p.26 |
| Eligibility to centralised procedure agreed date | 15 December 2011 | EU · p.6 |
| SGLT4 selectivity | >3500 fold lower | · p.14 |
| CHMP positive opinion date | 17-20 March 2014 | Jardiance (empagliflozin) · EU · p.8 |
| SGLT2 inhibition IC50 | 1.7 nM | · p.14 |
| SGLT1 selectivity | 5000 fold lower | · p.14 |
| Procedure start date | 27 March 2013 | EU · p.7 |
| SGLT5 selectivity | >350 fold lower | · p.14 |
| SGLT6 selectivity | >600 fold lower | · p.14 |
| ED50 for increased urine glucose concentrations | 0.9 mg/kg | · p.14 |
| Blood glucose reduction after single dose | 46 % | · p.14 |
| Application submission date | 5 March 2013 | Jardiance (empagliflozin) · EU · p.6 |
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 →