BOEHRINGER INGELHEIM — Glyxambi FDA Review (NDA/BLA 206073, 2021)
Boehringer Ingelheim · 2021 · FDA Review (Drugs@FDA)
Report summary
The FDA approved GLYXAMBI (empagliflozin/linagliptin) on July 3, 2019, for type 2 diabetes, citing its role in glycemic control and empagliflozin's cardiovascular death risk reduction. Warnings include pancreatitis, ketoacidosis, and acute kidney injury. Safety data from clinical trials and postmarketing surveillance detail adverse reactions like bullous pemphigoid and increased LDL-C. Pharmacokinetic interactions and efficacy data are also provided. The CARMELINA trial, a post-marketing requirement for linagliptin, demonstrated its cardiovascular safety, showing non-inferiority for major adverse cardiovascular events (MACE) and no increased risk of heart failure. This trial's findings influenced labeling updates for linagliptin-containing products, including GLYXAMBI.
Key findings — cited to the page
| Approval Date | 07/03/2019 | GLYXAMBI · p.1 |
| FDA approval date | May 2, 2011 | Linagliptin · United States · p.87 |
| Approval date | May 27, 2016 | Jentadueto XR (linagliptin and extended release metformin) · United States · p.77 |
| Approval date | January 30, 2015 | Glyxambi (linagliptin and empagliflozin) · United States · p.77 |
| Percentage of randomized subjects from U.S. | 15 % | CARMELINA · United States · p.107 |
| FDA approval date | May 27, 2016 | Jentadueto XR (linagliptin and metformin extended-release) · United States · p.87 |
| FDA approval date | January 30, 2015 | Glyxambi (linagliptin and empagliflozin) · United States · p.87 |
| FDA approval date | January 30, 2012 | Jentadueto (linagliptin and metformin HCl) · United States · p.87 |
| Randomized subjects from U.S. | 1059 | CARMELINA · United States · p.107 |
| Approval date | May 2, 2011 | Tradjenta (linagliptin) · United States · p.77 |
| Approval date | January 30, 2012 | Jentadueto (linagliptin and metformin HCl) · United States · p.77 |
| Indication | adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus | GLYXAMBI · p.1 |
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 →