Novo Nordisk A S — Awiqli EMA EPAR public assessment report (EMEA/H/C/005978, 2024)
Novo Nordisk A S · 2024 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's assessment report for Awiqli (insulin icodec) details its development as a novel once-weekly basal insulin for adults with diabetes. The report covers its manufacturing, non-clinical pharmacology, pharmacokinetics, and toxicology, highlighting its extended action and long half-life. The comprehensive ONWARDS clinical trial program (Phase 2 and 3a) demonstrated Awiqli's efficacy in reducing HbA1c, showing non-inferiority or superiority compared to daily basal insulins in various type 1 and type 2 diabetes populations. However, Awiqli was associated with a higher incidence of hypoglycemic events, particularly in type 1 diabetes, and a longer time to reach glycemic targets. The safety profile also noted increased medication errors and some skeletal abnormalities in animal studies. Risk minimization strategies are outlined, and Awiqli is included in the additional monitoring list.
Key findings — cited to the page
| T1DM trial duration (weeks) | 26 weeks | insulin icodec · p.12 |
| Insulin icodec half-life | 1 week | Insulin icodec · p.12 |
| CHMP positive opinion date | 21 March 2024 | Awiqli · EU · p.9 |
| T2DM trial duration (weeks) | 26-52 weeks | insulin icodec · p.12 |
| Insulin icodec concentration | 700 units/mL | Awiqli · p.12 |
| Insulin icodec molecular weight | 6380 Da | Insulin icodec · p.12 |
| Application submission date | 4 April 2023 | Awiqli · EU · p.6 |
| Number of phase 2 exploratory trials | 3 | insulin icodec · p.11 |
| Number of phase 3a confirmatory trials | 6 | insulin icodec · p.11 |
| Number of T2DM phase 3 studies | 5 | insulin icodec · p.12 |
| Number of T1DM phase 3 studies | 1 | insulin icodec · p.12 |
| In-use period | 12 weeks | Insulin icodec · p.27 |
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 →