Johnson & Johnson — Invokana EMA EPAR variation assessment report (EMEA/H/C/002649, 2013)
Johnson & Johnson · 2013 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the Type II variation application for Invokana (canagliflozin) to extend its indication to pediatric patients aged 10 years and older with type 2 diabetes mellitus. Two clinical studies, DIA3018 and DIA1055, supported the application, evaluating pharmacokinetics, pharmacodynamics, efficacy, and safety. Study DIA3018, a Phase 3 trial, demonstrated significant reductions in HbA1c (-0.76% vs. placebo at week 26) and FPG, and a reduction in body weight. The safety profile in pediatric patients was consistent with adults, with common adverse events including headache and nasopharyngitis, and a lower incidence of hypoglycemia compared to placebo. The CHMP recommended approval of this variation.
Key findings — cited to the page
| Study JNJ-28431754DIA1055 inclusion criteria HbA1c range | ≥6.1% to ≤10% % | JNJ-28431754DIA1055 · p.13 |
| Canagliflozin US approval date | 29 March 2013 | Invokana (canagliflozin) · United States · p.9 |
| eGFR exclusion criteria | <60 mL/min/1.73m2 | DIA3018 · p.28 |
| Canagliflozin EU Marketing Authorization date | 15 November 2013 | Invokana (canagliflozin) · EU · p.9 |
| Countries where Canagliflozin is authorized | more than 60 | Invokana (canagliflozin) · Global · p.9 |
| Study JNJ-28431754DIA3018 design | double-blind, placebo-controlled, 2-arm, parallel-group, multicenter Phase 3 study | JNJ-28431754DIA3018 · p.6 |
| Study JNJ-28431754DIA3018 population HbA1c range | >6.5% to <11.0% % | JNJ-28431754DIA3018 · p.6 |
| Study JNJ-28431754DIA1055 design | Open-Label, Multicenter, Multiple Oral Dose Study | JNJ-28431754DIA1055 · p.9 |
| Study JNJ-28431754DIA1055 background therapy | stable regimen of metformin (≥1,000 mg per day) for ≥8 weeks | JNJ-28431754DIA1055 · p.12 |
| Study JNJ-28431754DIA1055 planned enrollment | 16 subjects | JNJ-28431754DIA1055 · p.13 |
| Study JNJ-28431754DIA1055 analyzed enrollment | 17 subjects | JNJ-28431754DIA1055 · p.13 |
| Number of participants in PopPK model development | 1616 | · p.18 |
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 →