Johnson & Johnson — Invokana EMA EPAR public assessment report (EMEA/H/C/002649, 2013)
Johnson & Johnson · 2013 · EMA EPAR public assessment report · company profile →
Report summary
This EMA report details the regulatory assessment of Canagliflozin (Invokana) for type 2 diabetes. It covers the product's indication, pharmaceutical form, and manufacturing. Non-clinical studies in animals showed SGLT2 inhibition, dose-dependent glucose excretion, and species-specific toxicological findings deemed irrelevant to humans. Clinical trials demonstrated significant, durable reductions in HbA1c, fasting plasma glucose, and body weight across various patient populations and background therapies, including superiority over placebo and some active comparators. Pharmacokinetic data highlighted absorption, distribution, metabolism, and elimination, with considerations for renal impairment and elderly patients. Safety analysis revealed increased rates of genital and urinary tract infections, volume depletion, and a small excess of bone fractures. The benefit-risk profile was deemed negative for eGFR below 45 mL/min/1.73m2. The CHMP recommended marketing authorization for Invokana as monotherapy or add-on therapy.
Key findings — cited to the page
| NOEC for Daphnia sp. Reproduction Test | 0.56 mg/L | · p.26 |
| Systolic Blood Pressure change from baseline (mmHg) | -5.06 mmHg | DIA3006 · p.49 |
| Number of subjects treated | 157 | DIA3002 · p.54 |
| HbA1c change from baseline (%) | -0.66 % | DIA3006 · p.49 |
| Body weight change from baseline (placebo-adjusted %) | -2.9 % | DIA3006 · p.49 |
| Systolic Blood Pressure change from baseline (mmHg) | -3.84 mmHg | DIA3006 · p.49 |
| HbA1c change from baseline (%) | -0.77 % | DIA3006 · p.49 |
| Body weight change from baseline (placebo-adjusted %) | -2.5 % | DIA3006 · p.49 |
| Marketing Authorisation Date | 6 September 2013 | Canagliflozin · Australia · p.13 |
| HbA1c change from baseline (%) | -0.62 % | DIA3006 · p.49 |
| CHMP positive opinion date | 19 September 2013 | Invokana · p.14 |
| Systolic Blood Pressure change from baseline (mmHg) | 1.52 mmHg | DIA3006 · p.49 |
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 →