Boehringer Ingelheim — Synjardy FDA Review (NDA206111, ORIG 1, 2015)
Boehringer Ingelheim · 2015 · FDA Review (openFDA)
Report summary
This FDA review evaluates Boehringer Ingelheim's New Drug Application (NDA 206111) for Synjardy, a fixed-dose combination of empagliflozin and metformin HCl. The review synthesizes efficacy and safety data, largely from previous empagliflozin trials (NDA 204629), alongside bridging studies for dosing and combination product administration. Efficacy in glycemic control was demonstrated, with safety profiles generally consistent with empagliflozin alone. Key safety concerns addressed include decreased renal function, hepatic injury, urinary and genital infections, hypoglycemia, volume depletion, malignancy, and fractures. While some adverse events showed slight variations in incidence, the overall safety profile was manageable. Initially, a Complete Response was recommended due to labeling disagreements, but the final recommendation shifted to approval pending resolution of these issues, confirming the application's fileability from a clinical perspective.
Key findings — cited to the page
| Efficacy and safety data duration | 52 week | 1245.28 · p.4 |
| Empagliflozin median time to peak plasma concentration | 1 hour | · p.23 |
| PDUFA Goal Date | June 4, 2015 | · p.7 |
| Application Type | New Combination NDA | · p.7 |
| Application Number | NDA-206111 | · p.7 |
| Dosing Regimen | 5/500 mg, 5/1000 mg, 12.5/500 mg, and 12.5/1000 mg mg | SYNJARDY · p.7 |
| Indication | Adjunct to diet and exercise to improve glycemic control in adult subjects with type 2 diabetes mellitus | · p.7 |
| Recommendation on Regulatory Action | approval | · p.16 |
| NDA submission date | August 4, 2014 | NDA-206111 (Empagliflozin and metformin fixed combination drug product) · United States · p.18 |
| Applicant | Boehringer Ingelheim | · p.7 |
| Proposed Trade Name | SYNJARDY | SYNJARDY · p.7 |
| Empagliflozin apparent steady-state volume of distribution | 180-230 L | · p.23 |
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 →