JANSSEN PHARMS — Invokana FDA Review (NDA/BLA 204042, 2020)
Johnson & Johnson · 2020 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved a supplemental New Drug Application for Invokana (canagliflozin) in 2015, updating its label to include new safety information regarding ketoacidosis and urosepsis, and requiring a postmarketing study for ketoacidosis. Clinical trials demonstrated Invokana's efficacy in reducing HbA1c, FPG, and body weight, both as monotherapy and in combination with other antidiabetic agents. However, safety concerns arose from adverse events like genital infections, volume depletion, renal issues, and changes in lab parameters. Post-marketing surveillance, including FAERS data, identified ketoacidosis, urosepsis, and pyelonephritis as significant safety signals, leading to label changes and a mandated five-year enhanced pharmacovigilance study for ketoacidosis.
Key findings — cited to the page
| Initial U.S. Approval | 2013 | INVOKANA · United States · p.11 |
| PMR Interim Report Submission | 12/2019 | canagliflozin · p.6 |
| NDA/BLA Number | 204042Orig1s013 | INVOKANA · p.1 |
| Indication | adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus | INVOKANA · p.1 |
| Approval Date | 12/04/2015 | INVOKANA · p.1 |
| PMR Interim Report Submission | 12/2018 | canagliflozin · p.6 |
| sNDA received date | October 21, 2015 | Invokana · p.4 |
| Risk of ketoacidosis and urosepsis | new safety information | Invokana · p.4 |
| Postmarketing Requirement (PMR) for ketoacidosis study | 3005-1 | canagliflozin · p.6 |
| PMR Final Protocol Submission | 06/2016 | canagliflozin · p.6 |
| PMR Interim Report Submission | 12/2017 | canagliflozin · p.6 |
| PMR Interim Report Submission | 12/2020 | canagliflozin · p.6 |
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 →