Novo Nordisk A S — Ryzodeg EMA EPAR variation assessment report (EMEA/H/C/002499, 2013)
Novo Nordisk A S · 2013 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the assessment of Novo Nordisk A/S's Type II variation application for Ryzodeg (insulin degludec/insulin aspart) to extend its indication to pediatric patients aged 1-18 years with Type 1 Diabetes Mellitus. Two key trials, 3816 and 3561, supported the application. Trial 3816 showed non-inferiority of IDegAsp to insulin detemir (IDet) in HbA1c reduction, but a numerically higher rate of severe hypoglycemia with IDegAsp, especially in younger children. Trial 3561 confirmed non-inferiority of IDeg/IDegAsp to IDet for HbA1c, with comparable glycemic control and lower total insulin doses. While safety profiles were generally similar, severe hypoglycemia was a concern, particularly in the 2-5 year age group. Despite these safety considerations, the CHMP recommended approval for the extended indication, with specific guidance for prescribers regarding the youngest pediatric patients.
Key findings — cited to the page
| IDegAsp approval in adults (EU) | 21 January 2013 | Ryzodeg · EU · p.7 |
| Trial 3816 population age | 1 to less than 18 years years | Trial 3816 · p.7 |
| Application Submission Date | 12 October 2015 | Ryzodeg · p.5 |
| IDegAsp composition | 70% IDeg and 30% IAsp | Ryzodeg · p.7 |
| IDeg approval in adolescents and children (EU) | January 2015 | Tresiba · EU · p.7 |
| Trial 3816 duration | 16 weeks | Trial 3816 · p.7 |
| Trial 3816 US sites enrolment percentage | 20−25 % | Trial 3816 · United States · p.17 |
| Procedure Number | EMEA/H/C/002499/II/0017 | Ryzodeg · p.1 |
| subjects from U.S. | 32 % | Trial 3816 · United States · p.20 |
| subjects from Israel | 9 % | Trial 3816 · Israel · p.20 |
| subjects from Russian Federation | 13 % | Trial 3816 · Russia · p.20 |
| Trial 3561 duration | 26 weeks | Trial 3561 · p.8 |
Source: Novo Nordisk A S ↗ · 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 →