Novo Nordisk A S — Ryzodeg EMA EPAR public assessment report (EMEA/H/C/002499, 2013)
Novo Nordisk A S · 2013 · EMA EPAR public assessment report · company profile →
Report summary
The CHMP granted marketing authorization for Ryzodeg (insulin degludec/insulin aspart) for adult diabetes treatment, citing a positive benefit-risk balance. Non-clinical studies showed no significant safety concerns. Clinical trials demonstrated Ryzodeg's non-inferiority in HbA1c reduction compared to other insulins, with a flatter glucose-lowering profile and reduced nocturnal hypoglycemia in Type 1 Diabetes. While some Type 2 Diabetes trials showed higher overall hypoglycemia with once-daily Ryzodeg versus insulin glargine, this was attributed to the aspart component and mitigated by mealtime administration. The safety profile was generally acceptable, with risks like hypoglycemia managed through pharmacovigilance.
Key findings — cited to the page
| Indication granted | Treatment of diabetes mellitus in adults | Ryzodeg · p.8 |
| Recommended total daily starting dose for T2DM | 10 units | IDegAsp · p.8 |
| Recommended starting dose for T1DM | 60–70 % | IDegAsp · p.8 |
| Strength of IDegAsp | 100 U/ml | IDegAsp · p.8 |
| Insulin degludec concentration in IDegAsp | 420 nmol/ml | IDegAsp · p.8 |
| Insulin degludec percentage in IDegAsp | 70 % | IDegAsp · p.8 |
| Insulin aspart concentration in IDegAsp | 180 nmol/ml | IDegAsp · p.8 |
| Insulin aspart percentage in IDegAsp | 30 % | IDegAsp · p.8 |
| Dose range of PDS290 pen-injector | 1-80 U/injection | IDegAsp · p.8 |
| Insulin degludec concentration in Ryzodeg | 420 nmol/ml | Ryzodeg · p.9 |
| Insulin degludec percentage in Ryzodeg | 70 % | Ryzodeg · p.9 |
| Application submission date | 26 September 2011 | Ryzodeg · p.5 |
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 →