Johnson & Johnson — Vokanamet EMA EPAR public assessment report (EMEA/H/C/002656, 2014)
Johnson & Johnson · 2014 · EMA EPAR public assessment report · company profile →
Report summary
This EMA report assesses Vokanamet (canagliflozin/metformin) for marketing authorization in adults with type 2 diabetes. It covers the product's composition, regulatory background, and non-clinical data, including pharmacology, pharmacokinetics, and toxicology of canagliflozin and metformin. Species-specific toxicities in rats were identified but deemed not relevant to humans. Clinical studies demonstrated Vokanamet's efficacy in reducing HbA1c, fasting plasma glucose, and body weight, both as monotherapy and add-on therapy. The safety profile, including adverse events, laboratory findings, and cardiovascular outcomes, was deemed acceptable with appropriate labeling and a robust pharmacovigilance plan. The benefit-risk balance for Vokanamet was concluded to be favorable.
Key findings — cited to the page
| NOEC for Daphnia sp. Reproduction Test (metformin) | 100 mg/L | · p.41 |
| NOEC for Daphnia sp. Reproduction Test (canagliflozin) | 0.56 mg/L | · p.40 |
| Marketing Authorisation Application submission date | 4 March 2013 | Vokanamet · p.11 |
| Marketing Authorisation Date | 15 November 2013 | Invokana · EU · p.130 |
| Scientific Advice date | 22 October 2009 | · p.12 |
| Scientific Advice date | 21 October 2010 | · p.12 |
| CHMP positive opinion date | 20 February 2014 | Vokanamet · p.13 |
| Procedure start date | 27 March 2013 | · p.12 |
| Scientific Advice date | 19 March 2009 | · p.12 |
| Strength | 150 mg / 1000 mg | Vokanamet · p.2 |
| Centralised procedure eligibility agreement date | 17 November 2011 | · p.11 |
| 24-month Exposure (CANA Total) | 679 | Phase 3 Program · p.90 |
Source: Johnson & Johnson ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →