Regulatory Decision Summary for Entuzity

The efficacy and safety of Entuzity were assessed in a 24-week, randomized, open-label clinical trial conducted in patients with type 2 diabetes mellitus who had inadequate glycemic control despite taking more than 200 units of insulin per day. Although all patients in the study received Entuzity, they were randomized to receive their daily dose of Entuzity either two or three times a day. In these patients, Entuzity taken two or three times a day reduced hemoglobin A1c (HbA1c) compared to baseline in a clinically meaningful and statistically significant manner.

Entuzity is a concentrated insulin product. The benefit of using Entuzity over non-concentrated insulin products is the ability to administer more units of insulin per injection which may reduce the number of injections and/or the total volume of injections required daily.

Overall, the safety profile of Entuzity is similar to the already well-established safety profile of other human insulin products, with no new or unexpected findings. However, because Entuzity is a highly-concentrated insulin product, there is potential for an increased risk for hypoglycemia.

The evaluation of efficacy and safety is further supported by over 20 years of post-marketing experience in the United States where Entuzity has been used since 1997 to treat adults and children with diabetes mellitus with high daily insulin requirements.

The benefit/risk ratio for Entuzity is considered favourable. However, in order to ensure that the benefit continues to outweigh any risk after authorization, Health Canada has required standard post-approval activities to be carried out as well as a Risk Management Plan.