Insulin icodec explained

Tradename:Awiqli
Pregnancy Au:B3
Routes Of Administration:Subcutaneous
Atc Prefix:A10
Atc Suffix:AE07
Legal Au:S4
Legal Au Comment:[1]
Legal Ca:Rx-only
Legal Ca Comment:/Schedule D[2] [3]
Legal Eu:Rx-only
Legal Eu Comment:[4]
Cas Number:1188379-43-2
Drugbank:DB16693
Unii:P7YU3ED05N
Kegg:D12358
Iupac Name:(1a-21a),(1b-29b)-Insulin (human), 14a-L-glutamic acid-16b-L-histidine-25b-L-histidine-29b-(N6-(N-(19-carboxy-1-oxononadecyl)-L-gamma-glutamyl-2-(2-(2-aminoethoxy)ethoxy)acetyl-2-(2-(2-aminoethoxy)ethoxy)acetyl)-L-lysine)-
C:280
H:435
N:71
O:87
S:6

Insulin icodec, sold under the brand name Awiqli, is a medication used for the treatment of diabetes to improve glycemic control. It is an ultralong-acting basal insulin analogue that is developed by Novo Nordisk.

It has a plasma half-life more than eight days[5] (compared to 25 hours of the previous longest-acting insulin analogue insulin degludec), making it a once-weekly basal insulin.

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.[6]

Society and culture

Legal status

Insulin icodec was approved for medical use in Canada in March 2024.

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. The applicant for this medicinal product is Novo Nordisk A/S.[7] Insulin icodec was approved for medical use in the European Union in May 2024.

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]

Notes and References

  1. Web site: Awiqli (insulin icodec) . Therapeutic Goods Administration (TGA) . 28 July 2024 . 12 October 2024.
  2. Web site: Regulatory Decision Summary for Awiqli . Drug and Health Products Portal . 12 March 2024 . 1 April 2024 . 1 April 2024 . https://web.archive.org/web/20240401064124/https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1711383693011 . live .
  3. Web site: Awiqli Product information . . 12 March 2024 . 1 April 2024 . 1 April 2024 . https://web.archive.org/web/20240401064124/https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103492 . live .
  4. Web site: Awiqli Product information . Union Register of medicinal products . 21 May 2024 . 27 May 2024 . 22 May 2024 . https://web.archive.org/web/20240522133712/https://ec.europa.eu/health/documents/community-register/html/h1815.htm . live .
  5. Kjeldsen TB, Hubálek F, Hjørringgaard CU, Tagmose TM, Nishimura E, Stidsen CE, Porsgaard T, Fledelius C, Refsgaard HH, Gram-Nielsen S, Naver H, Pridal L, Hoeg-Jensen T, Jeppesen CB, Manfè V, Ludvigsen S, Lautrup-Larsen I, Madsen P . Molecular Engineering of Insulin Icodec, the First Acylated Insulin Analog for Once-Weekly Administration in Humans . Journal of Medicinal Chemistry . 64 . 13 . 8942–8950 . July 2021 . 33944562 . 10.1021/acs.jmedchem.1c00257 . 233718893 . free .
  6. Nishimura E, Pridal L, Glendorf T, Hansen BF, Hubálek F, Kjeldsen T, Kristensen NR, Lützen A, Lyby K, Madsen P, Pedersen TÅ, Ribel-Madsen R, Stidsen CE, Haahr H . 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. August 2021 . 34413118 . 8378355 . 10.1136/bmjdrc-2021-002301 .
  7. Web site: Awiqli EPAR . European Medicines Agency . 21 March 2024 . 23 March 2024 . 23 March 2024 . https://web.archive.org/web/20240323162038/https://www.ema.europa.eu/en/medicines/human/EPAR/awiqli . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  8. ((World Health Organization)) . 2021 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85 . WHO Drug Information . 35 . 1 . 10665/340684 . free . World Health Organization .
  9. Rosenstock J, Bain SC, Gowda A, Jódar E, Liang B, Lingvay I, Nishida T, Trevisan R, Mosenzon O . Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin . The New England Journal of Medicine . 389 . 4 . 297–308 . July 2023 . 37356066 . 10.1056/NEJMoa2303208 . 259249866 . free .

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