Awiqli
Metabolic· 1067 cited findings· 1 source document
Company: Novo Nordisk A S →
What the regulatory reviews say
Awiqli is an insulin icodec, a new active substance, for which a positive opinion was issued by the CHMP on 21 March 2024, following an application submitted on 4 April 2023. It is included on the additional monitoring list. The drug has a duration of action of 7 days, a tmax of 24 hours, and a t½ of 63 hours. Its potency for HbA1c reduction is 40-50% compared to NPH human insulin.
In clinical trials, serious adverse events (SAEs) for insulin icodec were observed in approximately 8% of patients in the T2DM pool and 3.8% in the T1DM population. In the ONWARDS 2 study, serious AEs for insulin icodec were 8.4% compared to 6.1% for daily basal insulin. The Time Below Range (TBR) <3.0 mmol/L was 1.02% for insulin icodec versus 0.68% for the comparator, and TBR <3.9 mmol/L was 3.86% for insulin icodec versus 2.90% for the comparator. The rate of level 2 or 3 hypoglycaemia was 1.89, and the rate of nocturnal hypoglycaemic episodes (level 2 or 3) was 2.13.
The drug has a shelf life of 30 months and an in-use period of 12 weeks. The development program included 3 phase 2 exploratory trials and 6 phase 3a confirmatory trials, with 5 studies in T2DM (26-52 weeks duration) and 1 study in T1DM (26 weeks duration).
Key figures — cited to the source page
| Potency of insulin icodec vs NPH human insulin (HbA1c reduction) | 40-50 | Novo Nordisk A S — Awiqli EMA EPAR public assessment report, p.31 |
| Serious AEs (ONWARDS 2, insulin icodec) | 8.4 | Novo Nordisk A S — Awiqli EMA EPAR public assessment report, p.137 |
| Serious AEs (ONWARDS 2, daily basal insulin) | 6.1 | Novo Nordisk A S — Awiqli EMA EPAR public assessment report, p.137 |
| Time Below Range (TBR) <3.0 mmol/L | 1.02 | Novo Nordisk A S — Awiqli EMA EPAR public assessment report, p.133 |
| Time Below Range (TBR) <3.0 mmol/L (comparator) | 0.68 | Novo Nordisk A S — Awiqli EMA EPAR public assessment report, p.133 |
| Rate of level 2 or 3 hypoglycaemia | 1.89 | Novo Nordisk A S — Awiqli EMA EPAR public assessment report, p.133 |
| CHMP positive opinion date | 21 March 2024 | Novo Nordisk A S — Awiqli EMA EPAR public assessment report, p.9 |
| Additional monitoring list inclusion | true | Novo Nordisk A S — Awiqli EMA EPAR public assessment report, p.176 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.