Insulin icodec
| Clinical data | |
|---|---|
| Trade names | Awiqli |
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| Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
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| Chemical and physical data | |
| Formula | C280H435N71O87S6 |
| Molar mass | 6380.33 g·mol−1 |
Insulin icodec, sold under the brand name Awiqli, is a medication used for the treatment of diabetes to improve glycemic control.[3] It is an ultralong-acting basal insulin analogue that is developed by Novo Nordisk.[3]
It has a plasma half-life more than eight days[6] (compared to 25 hours of the previous longest-acting insulin analogue insulin degludec), making it a once-weekly basal insulin.[6]
Like insulin, icodec is composed of two peptide chains linked by a disulfide bridge. However, a C20 fatty diacid-containing side chain has been added for strong, reversible albumin binding; and three amino acid substitutions provide molecular stability and attenuate insulin receptor binding and clearance. Together, these modifications prolong the half-life.[7]
Society and culture
Legal status
Insulin icodec was approved for medical use in Canada in March 2024.[3]
In March 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Awiqli, intended for the treatment of diabetes.[4] The applicant for this medicinal product is Novo Nordisk A/S.[4] Insulin icodec was approved for medical use in the European Union in May 2024.[5]
Names
Insulin icodec is the international nonproprietary name.[8]
Research
Based on a clinical trial, glycemic control was found to be non-inferior with once-weekly insulin icodec compared with once-daily insulin glargine U100.[9]
References
- ^ a b "Awiqli (insulin icodec)". Therapeutic Goods Administration (TGA). 28 July 2024. Retrieved 12 October 2024.
- ^ "Regulatory Decision Summary for Awiqli". Drug and Health Products Portal. 12 March 2024. Archived from the original on 1 April 2024. Retrieved 1 April 2024.
- ^ a b c d "Awiqli Product information". Health Canada. 12 March 2024. Archived from the original on 1 April 2024. Retrieved 1 April 2024.
- ^ a b c "Awiqli EPAR". European Medicines Agency. 21 March 2024. Archived from the original on 23 March 2024. Retrieved 23 March 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ a b "Awiqli Product information". Union Register of medicinal products. 21 May 2024. Archived from the original on 22 May 2024. Retrieved 27 May 2024.
- ^ a b Kjeldsen TB, Hubálek F, Hjørringgaard CU, Tagmose TM, Nishimura E, Stidsen CE, et al. (July 2021). "Molecular Engineering of Insulin Icodec, the First Acylated Insulin Analog for Once-Weekly Administration in Humans". Journal of Medicinal Chemistry. 64 (13): 8942–8950. doi:10.1021/acs.jmedchem.1c00257. PMID 33944562. S2CID 233718893.
- ^ Nishimura E, Pridal L, Glendorf T, Hansen BF, Hubálek F, Kjeldsen T, et al. (August 2021). "Molecular and pharmacological characterization of insulin icodec: a new basal insulin analog designed for once-weekly dosing". BMJ Open Diabetes Research & Care. 9 (1): e002301. doi:10.1136/bmjdrc-2021-002301. PMC 8378355. PMID 34413118.
- ^ World Health Organization (2021). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85". WHO Drug Information. 35 (1). hdl:10665/340684.
- ^ Rosenstock J, Bain SC, Gowda A, Jódar E, Liang B, Lingvay I, et al. (July 2023). "Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin". The New England Journal of Medicine. 389 (4): 297–308. doi:10.1056/NEJMoa2303208. PMID 37356066. S2CID 259249866.
