Regulatory Decision Summary for Awiqli

This new drug submission was for the authorization of a weekly basal insulin, Awiqli (insulin icodec injection), for the once-weekly treatment of adults with diabetes mellitus to improve glycemic control.

Awiqli (insulin icodec injection) was authorized based on 6 Phase 3, randomized, active-controlled studies in subjects with Type 1 (T1DM) and Type 2 (T2DM) diabetes. Overall, there were 290 T1DM and 1,880 T2DM patients exposed to insulin icodec across these trials.

The primary efficacy endpoint in all 6 studies was non-inferiority of Awiqli to daily-administration basal insulin comparators, defined as a difference in treatment effect of less than 0.3 %-points in HbA1c after 26 or 52 weeks of treatment. All 6 studies met this endpoint.

In T2DM, subjects treated with Awiqli showed similar or better profiles for other glycemic endpoints such as achievement of HbA1c <7% without experiencing severe or clinically significant hypoglycemia and fasting plasma glucose.

T1DM patients treated with Awiqli showed a similar or less favourable profile for endpoints such as fasting plasma glucose and achievement of HbA1c thresholds. This was attributable to a consistently higher incidence of all degrees of hypoglycemic events in Awiqli-treated patients with T1DM. The majority of these events were mild or moderate.

Overall, patients treated with Awiqli tended to have a greater incidence of hypoglycemic events, particularly on days 2-4 of the weekly dosing cycle. This corresponds to the pharmacokinetic profile for insulin icodec where exposure is highest early in the week.

Overall, based on the data evaluated as part of this submission and risk management measures in labelling and pharmacovigilance plans, the benefit-risk profile of Awiqli is considered favourable for adults with Type 1 or Type 2 diabetes who require basal insulin for glycemic control.

An updated Risk Management Plan (RMP) Awiqli was reviewed by Health Canada and considered acceptable. Risks have been communicated in the approved Product Monograph and will continue to be monitored post market as outlined in the Risk Management Plan, with routine and non-routine pharmacovigilance activities.

The chemistry and manufacturing information submitted for Awiqli has demonstrated that the drug substance and drug product can be consistently manufactured to meet the approved specifications.

Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.

Overall, the benefit-harm-uncertainty profile was favourable for Awiqli for the approved indication when used under the conditions of use recommended in the approved Product Monograph. Therefore, a Notice of Compliance (NOC) was recommended.

For further details about Awiqli, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.