BOEHRINGER INGELHEIM — Glyxambi FDA Review (NDA/BLA 206073, 2021)
Boehringer Ingelheim · 2021 · FDA Review (Drugs@FDA)
Report summary
The FDA approved GLYXAMBI (empagliflozin and linagliptin) for type 2 diabetes, detailing indications, dosage, and contraindications. Safety information includes postmarketing hypersensitivity, severe arthralgia, and adverse reaction rates from clinical trials (e.g., UTIs, genital mycotic infections). The drug's efficacy and safety were evaluated in patients inadequately controlled on metformin, with cardiovascular outcome data from EMPA-REG OUTCOME, CARMELINA, and CAROLINA trials. Serious side effects include pancreatitis, ketoacidosis, and kidney problems. The CAROLINA trial, comparing linagliptin to glimepiride, established linagliptin's non-inferiority for cardiovascular safety (3P-MACE) and a lower incidence of hypoglycemia. Regulatory inspections revealed some site non-compliance, but these issues did not significantly impact primary safety and efficacy analyses. GLYXAMBI and related linagliptin products received concurrent approval based on these findings.
Key findings — cited to the page
| Linagliptin dose | 5 mg once daily | CAROLINA · p.91 |
| HbA1c change from baseline | -1.2 % | · p.33 |
| Indication | adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus | GLYXAMBI · United States · p.1 |
| Approval Date | 03/30/20 | GLYXAMBI · United States · p.1 |
| HbA1c change from baseline | -1.1 % | · p.33 |
| Approval date | May 2, 2011 | Tradjenta · United States · p.49 |
| Approval date | January 27, 2020 | Trijardy XR · United States · p.49 |
| Approval date | July 3, 2019 | CARMELINA sNDAs · United States · p.49 |
| PDUFA Goal Date | March 30, 2020 | United States · p.60 |
| Tradjenta US approval date | May 2, 2011 | Tradjenta · United States · p.81 |
| Indication (Empagliflozin component) | reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease | Empagliflozin · United States · p.1 |
| HbA1c change from baseline | -0.7 % | · p.33 |
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 →