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Awiqli (insulin icodec)
Australian Prescription Medicine Decision Summary
ARTGs
Device/Product name
Awiqli
Active Ingredient
insulin icodec
Date of decision
Published
Submission type
Type A - New chemical entity
ATC codes
A10AE07 - Insulins and analogues for injection, long-acting
Decision
Approved
What was the decision based on
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.
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.
What steps were involved in the decision process
This submission was evaluated under the standard prescription medicines registration process.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 17 May 2023 |
| Evaluation completed | 8 December 2023 |
| Delegate’sa Overall benefit-risk assessment and request for Advisory Committee advice | 8 March 2024 |
| Advisory Committee meeting | 4 April 2024 |
| Registration decision (Outcome) | 17 May 2024 |
| Administrative activities and registration in the ARTG completed | 28 June 2024 |
| Number of working days from submission dossier acceptance to registration decisionb | 285 |
a The ‘Delegate’ is the Delegate of the Secretary of the Department of Health and Aged Care who made the final decision to either include the new medicine/indication on the ARTG or reject the submission, under section 25 of the Therapeutic Goods Act.
b Statutory timeframe for standard submissions is 255 working days
Date of entry onto ARTG
Black triangle scheme
Awiqli is to be included in the Black Triangle Scheme. The PI and CMI for Awiqli must include the black triangle symbol and mandatory accompanying text for five years, or the product’s entire period of provisional registration, whichever is longer. The black triangle is a visual reminder to encourage health practitioners and patients to report a problem or side effect with this medicine.
Dose forms
Clear and colourless solution.
Strength
1 mL solution contains 700 units of insulin icodec (equivalent to 26.8 mg insulin icodec).
Other ingredients
• Glycerol
• Metacresol
• Phenol
• Zinc acetate
• Sodium chloride
• Hydrochloric acid (for pH adjustment)
• Sodium hydroxide (for pH adjustment)
• Water for injections
Containers
1.5 or 3 mL solution in a cartridge (Type I glass) with a plunger (halobutyl) and a laminated rubber sheet (halobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene, polyoxymethylene, polycarbonate and acrylonitrile butadiene styrene.
Pack sizes
Awiqli pre-filled pen (FlexTouch) containing 700 units of insulin icodec in 1 mL solution.
• 1 pre-filled pen (with and without disposable NovoFine Plus needles).
Awiqli pre-filled pen (FlexTouch) containing 1,050 units of insulin icodec in 1.5 mL solution.
• 1 pre-filled pen (with and without disposable NovoFine Plus needles).
Awiqli pre-filled pen (FlexTouch) containing 2,100 units of insulin icodec in 3 mL solution.
• 1 pre-filled pen (with and without disposable NovoFine Plus needles).
• 1 pre-filled pen (with and without disposable NovoFine Plus needles).
Awiqli pre-filled pen (FlexTouch) containing 1,050 units of insulin icodec in 1.5 mL solution.
• 1 pre-filled pen (with and without disposable NovoFine Plus needles).
Awiqli pre-filled pen (FlexTouch) containing 2,100 units of insulin icodec in 3 mL solution.
• 1 pre-filled pen (with and without disposable NovoFine Plus needles).
Routes of administration
Subcutaneous injection
Dosage
Awiqli is available in one strength, 700 units/mL. The needed dose is dialled in units on the pre-filled pen. A dose of between 10-700 units per injection, in steps of 10 unit increments, can be administered. Awiqli is to be dosed in accordance with the individual patient’s needs.
Pregnancy category
B3
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
There is no clinical experience with use of insulin icodec in pregnant women.
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
There is no clinical experience with use of insulin icodec in pregnant women.
What was approved
Awiqli (insulin icodec), a long-lasting insulin analogue, has been approved for the treatment of type 1 and type 2 diabetes in adults.
What is this medicine and how does it work
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.
What post-market commitments will the sponsor undertake
The Awiqli Risk Management Plan (RMP) as agreed with the TGA will be implemented in Australia. An obligatory component of RMPs is routine pharmacovigilance, which includes the submission of periodic safety update reports.
More information
The latest Product Information (PI) and Consumer Medicine Information (CMI) can be found by searching the Australian Register of Therapeutic Goods (ARTG).
Australian Public Assessment Reports (AusPARs) can be found by searching our AusPAR dataset.
The latest news and updates regarding therapeutic goods regulation can be found on our news page.