JANSSEN PHARMS — Invokana FDA Review (NDA/BLA 204042, 2021)
Johnson & Johnson · 2021 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved a supplemental New Drug Application for Invokana (canagliflozin) on October 29, 2018, to reduce major adverse cardiovascular events (MACE) in adults with type 2 diabetes and established cardiovascular disease, based on the CANVAS and CANVAS-R studies. Invokana, an SGLT2 inhibitor, demonstrated significant improvements in glycemic control and a 14% reduction in MACE risk. However, safety concerns include an approximate twofold increased risk of lower limb amputations, and a potential signal for renal cell carcinoma, which is being monitored. Other adverse events include genital mycotic infections, urinary tract infections, and volume depletion. The FDA mandated labeling changes to reflect these findings.
Key findings — cited to the page
| Renal cancer, N (%) | 2 (0.05%) | EMPA-REG · p.97 |
| Indication | as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus | INVOKANA (Canagliflozin) · p.1 |
| HbA1C change from baseline (%) | -1.03 % | · p.38 |
| HbA1C change from baseline (adjusted mean) | -1.03 % | · p.46 |
| Recommended starting dose | 100 mg once daily | INVOKANA (canagliflozin) · p.13 |
| Canagliflozin approval date (US) | March 29th 2013 | INVOKANA · United States · p.314 |
| Approval Date | March 3, 1995 | Glucophage · United States · p.62 |
| INVOKAMET approval date (US) | August 8th 2014 | INVOKAMET · United States · p.314 |
| Approval date for canagliflozin | March 29, 2013 | Invokana · United States · p.121 |
| Approval Date | 10/29/2018 | INVOKANA (Canagliflozin) · p.1 |
| Approval Date | March 29, 2013 | Invokana · United States · p.62 |
| Indication | to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease | INVOKANA (Canagliflozin) · p.1 |
Source: Johnson & Johnson ↗ · 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 →