Jardiance
Metabolic· 3163 cited findings· 4 source documents
Company: Boehringer Ingelheim
What the regulatory reviews say
Jardiance (empagliflozin) is indicated for the treatment of children aged 10 years and above with type 2 diabetes mellitus. It demonstrates an SGLT2 inhibition IC50 of 1.7 nM and exhibits high selectivity, with SGLT1 selectivity 5000 fold lower, SGLT4 selectivity >3500 fold lower, SGLT5 selectivity >350 fold lower, and SGLT6 selectivity >600 fold lower. In efficacy studies, empagliflozin showed an ED50 for increased urine glucose concentrations of 0.9 mg/kg and an ED50 for blood glucose reduction of 0.6 mg/kg, resulting in a 46% blood glucose reduction after a single dose. HbA1c reductions ranged from -0.57% to -0.85% in various assessments.
Safety data indicates that 17.3% of patients in the empagliflozin pooled group experienced UTI events in the US, compared to 14% in the placebo group. Premature treatment discontinuation due to adverse events ranged from 4.3% to 18.9%. The rate of serious adverse events (SAEs) for the empagliflozin pooled group was 3.8%, which was comparable to the placebo group at 3.8%. However, overall rates of hypoglycemia were higher in the empagliflozin pooled group (23.1%) compared to placebo (9.4%).
Jardiance received a CHMP positive opinion between March 17-20, 2014, and was approved on December 2, 2016. The application for regulatory review was submitted on March 5, 2013.
Key figures — cited to the source page
| SGLT2 inhibition IC50 | 1.7 nM | Boehringer Ingelheim — Jardiance EMA EPAR public assessment, p.14 |
| HbA1c reduction (%) | -0.85 % | Boehringer Ingelheim — Jardiance EMA EPAR public assessment, p.50 |
| Patients with UTI events in US (Empagliflozin pool) | 17.3 % | BOEHRINGER INGELHEIM — Jardiance FDA Review (NDA/BLA 204629,, p.226 |
| Patients with UTI events in US (Placebo) | 14 % | BOEHRINGER INGELHEIM — Jardiance FDA Review (NDA/BLA 204629,, p.226 |
| Rate of SAEs for empagliflozin pooled group | 3.8 % | Boehringer Ingelheim — Jardiance EMA EPAR variation assessme, p.57 |
| Overall rates of hypoglycaemia for empagliflozin pooled group | 23.1 % | Boehringer Ingelheim — Jardiance EMA EPAR variation assessme, p.58 |
| Overall rates of hypoglycaemia for placebo | 9.4 % | Boehringer Ingelheim — Jardiance EMA EPAR variation assessme, p.58 |
| Approval Date | December 2, 2016 | BOEHRINGER INGELHEIM — Jardiance FDA Review (NDA/BLA 204629,, p.1 |
Source documents
- BOEHRINGER INGELHEIM — Jardiance FDA Review (NDA/BLA 204629, 2021) (2021)
- Boehringer Ingelheim — Jardiance FDA Review (NDA204629, SUPPL 5, 2016) (2016)
- Boehringer Ingelheim — Jardiance EMA EPAR public assessment report (EMEA/H/C/002677, 2014) (2014)
- Boehringer Ingelheim — Jardiance EMA EPAR variation assessment report (EMEA/H/C/002677, 2014) (2014)
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.