Johnson & Johnson — Invokana FDA Review (NDA204042, SUPPL 32, 2019)
Johnson & Johnson · 2019 · FDA Review (openFDA) · company profile →
Report summary
This integrated FDA review concerns Johnson & Johnson's Invokana (canagliflozin) for chronic kidney disease in adults with type 2 diabetes, specifically its efficacy in reducing end-stage kidney disease, serum creatinine doubling, cardiovascular death, and heart failure hospitalization. The review, with a PDUFA goal date of September 27, 2019, primarily analyzes the CREDENCE trial. This randomized, double-blind study compared canagliflozin 100 mg daily to placebo, demonstrating statistically significant reductions in a composite renal and cardiovascular endpoint, and heart failure hospitalization. The report details statistical analysis, trial design, and baseline demographics. Safety findings from CREDENCE and CANVAS programs are also presented, covering adverse events like hypotension, fungal infections, lower limb amputations, acute kidney injury, and diabetic ketoacidosis, alongside changes in HbA1c, blood pressure, and weight. The review also outlines study procedures, adjudication processes for adverse events, and regulatory labeling updates.
Key findings — cited to the page
| Approved indication | To reduce the risk of end-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria > 300 mg/day | INVOKANA (Canagliflozin) · p.3 |
| Approval status | approved | INVOKANA (Canagliflozin) · p.12 |
| Renal cell carcinoma events (placebo arm) | 1 event | CREDENCE · p.15 |
| Proposed indication | Chronic kidney disease due to type 2 diabetes mellitus (disorder) | INVOKANA (Canagliflozin) · p.3 |
| Application type | Efficacy Supplement | INVOKANA (Canagliflozin) · p.2 |
| Approved SNOMED indication | Chronic kidney disease due to type 2 diabetes mellitus (disorder) | INVOKANA (Canagliflozin) · p.3 |
| Application number | NDA 204042 S.032 | INVOKANA (Canagliflozin) · p.2 |
| Priority or standard | Priority | INVOKANA (Canagliflozin) · p.2 |
| Submit date | 3/27/2019 | INVOKANA (Canagliflozin) · p.2 |
| Received date | 3/27/2019 | INVOKANA (Canagliflozin) · p.2 |
| PDUFA goal date | 9/27/2019 | INVOKANA (Canagliflozin) · p.2 |
| Effectiveness in reducing risk | reducing the risk of end-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure | INVOKANA (Canagliflozin) · p.12 |
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 →