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Awiqli (insulin icodec)
Australian Prescription Medicine Decision Summary
Published
Product name
Awiqli
Active ingredient
insulin icodec
Submission type
Type A - New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Awiqli (insulin icodec), a long-lasting insulin analogue, has been approved for the treatment of type 1 and type 2 diabetes in adults.
How this medicine works
Diabetes is a disease in which blood glucose levels are not adequately controlled and are often elevated. In type 1 diabetes this is because the pancreas cannot produce insulin, the hormone which allows cells to absorb glucose. In type II diabetes, the body initially becomes increasingly insensitive to the effects of insulin and eventually may lose the ability to produce sufficient quantities of insulin. Awiqli is an insulin analogue that has been modified for increased stability and longevity in the bloodstream. It performs the same function as the natural insulin produced in the body, stimulating cells to absorb glucose from the blood. By acting as an insulin replacement, Awiqli restores normal insulin levels, which normalises blood glucose levels, leading to a reduction in the symptoms and complications of diabetes.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor.
The efficacy and safety of once-weekly insulin icodec was established through 18 clinical trials including:
- 6 phase 3a confirmatory efficacy and safety trials (ONWARDS 1-6),
- 3 phase 2 exploratory trials and
- 9 clinical pharmacology trials.
Consumer Medicine Information (CMI)
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMIs can be accessed through the ARTG details hyperlinks below.
Product Information (PI)
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PIs can be accessed through the ARTG details hyperlinks below.
ARTG details
- AWIQLI insulin icodec 700 U in 1 mL solution for injection pre-filled pen (407360)
- AWIQLI insulin icodec 700 U in 1mL solution for injection pre-filled pen with disposable needles (407359)
- AWIQLI insulin icodec 1050 U in 1.5 mL solution for injection pre-filled pen (440652)
- AWIQLI insulin icodec 1050 U in 1.5 mL solution for injection pre-filled pen with disposable needles (440653)
- AWIQLI insulin icodec 2100 U in 3 mL solution for injection pre-filled pen (440650)
- AWIQLI insulin icodec 2100 U in 3 mL solution for injection pre-filled pen with disposable needles (440651)
Other resources
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.