BOEHRINGER INGELHEIM — Jardiance FDA Review (NDA/BLA 204629, 2021)
Boehringer Ingelheim · 2021 · FDA Review (Drugs@FDA)
Report summary
The FDA approved Jardiance (empagliflozin) for type 2 diabetes (T2DM) glycemic control and to reduce cardiovascular (CV) death in T2DM patients with established CV disease. Clinical trials, notably EMPA-REG OUTCOME, demonstrated significant reductions in HbA1c, fasting plasma glucose, and body weight. EMPA-REG OUTCOME also showed Jardiance significantly reduced CV death and hospitalization for heart failure, primarily driving superiority for 3-point MACE. Safety concerns included increased genital mycotic infections, urinary tract infections, and diabetic ketoacidosis, but no increased risk for amputations or malignancies. While some stroke imbalances were noted, they weren't deemed substantial for new warnings. Renal protective effects were not sufficiently evidenced.
Key findings — cited to the page
| Recommended dose | 10 mg once daily | JARDIANCE · p.10 |
| Maximum dose | 25 mg once daily | JARDIANCE · p.10 |
| Postmarketing Requirement - MACE upper bound 95% CI | 1.3 | EMPA-REG OUTCOME trial · p.5 |
| Indication | to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease | JARDIANCE · p.10 |
| Patients with UTI events in US (Placebo) | 14 % | United States · p.226 |
| Approval Date | December 2, 2016 | JARDIANCE · p.1 |
| Patients with UTI events in US (Empagliflozin pool) | 17.3 % | United States · p.226 |
| Approval Date | December 2, 2016 | Jardiance · p.4 |
| Limitation of Use | Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis | JARDIANCE · p.1 |
| Indication | as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus | JARDIANCE · p.1 |
| Indication | to reduce the risk of cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease | JARDIANCE · p.1 |
| eGFR threshold for initiation | 45 mL/min/1.73 m2 | JARDIANCE · p.10 |
Source: Boehringer Ingelheim ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →