Novo Nordisk A S — Kyinsu EMA EPAR public assessment report (EMEA/H/C/006279, 2025)
Novo Nordisk A S · 2025 · EMA EPAR public assessment report · company profile →
Report summary
Novo Nordisk A/S's Kyinsu (insulin icodec/semaglutide) marketing authorization application to the EMA details a fixed-dose combination for type 2 diabetes. The report confirms acceptable manufacturing, quality control, and a 3-year shelf-life. Non-clinical studies showed no objections. Phase 3a COMBINE trials demonstrated Kyinsu's superiority in HbA1c reduction and body weight compared to insulin icodec and semaglutide, and non-inferiority to basal-bolus insulin, with a lower incidence of severe hypoglycemia. Safety concerns include gastrointestinal events and a slightly higher incidence of diabetic retinopathy. Overall, the benefit-risk balance is positive, supporting marketing authorization.
Key findings — cited to the page
| Kyinsu maximum weekly dose (semaglutide) | 1 mg | Kyinsu · p.10 |
| In-use stability period | 6 weeks | Kyinsu (0.43 mL variant) · p.30 |
| CHMP positive opinion date | 18 September 2025 | Kyinsu · EU · p.7 |
| Kyinsu maximum weekly dose (insulin icodec) | 350 U | Kyinsu · p.10 |
| Shelf-life | 3 years | Kyinsu · p.29 |
| In-use stability period | 8 weeks | Kyinsu (1.5 mL and 1 mL variants) · p.30 |
| Application submission date | 7 October 2024 | Kyinsu · EU · p.6 |
| Procedure start date | 31 October 2024 | Kyinsu · EU · p.7 |
| Kyinsu recommended starting dose (semaglutide) | 0.114 mg | Kyinsu · p.10 |
| Kyinsu maximum weekly dose (dose steps) | 350 dose steps | Kyinsu · p.10 |
| Insulin icodec molecular weight | 6380 Da | Insulin icodec · p.12 |
| Storage temperature for in-use period | 30°C | Kyinsu · p.30 |
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 →