Recently, Novo Nordisk announced that the European Commission (EC) has granted marketing authorization for Awiqli (insulin icodec, a once-weekly basal insulin) for the treatment of adult patients with diabetes.50% of Type 2 diabetes patients requiring insulin therapy delay starting insulin for more than 2 years. Injection burden is one of the main barriers affecting insulin treatment adherence among Type 2 diabetes patients and physicians' initiation of insulin therapy.Icodec is a long-acting basal insulin analog. The molecule reduces its affinity for the insulin receptor while introducing an acyl modification, thereby achieving a half-life of up to 196 hours. After injection into the human body, Icodec can bind tightly but reversibly to albumin, providing continuous and stable blood glucose reduction throughout the week.
This new drug is also the first innovative achievement by Novo Nordisk to complete clinical trials in China, the EU, and the US simultaneously, and to submit new drug marketing applications concurrently.
However, the FDA advisory committee voted on May 24 not to recommend Icodec for patients with type 1 diabetes. Reviewers noted that the proportion of hypoglycemia in type 1 diabetes patients treated with Icodec was "significantly higher" compared to insulin degludec.In the Phase IIIa study, compared with daily injectable basal insulin, the weekly basal insulin icodec achieved greater reductions in blood glucose (measured by HbA1c changes) in patients with type 2 diabetes, and showed superior "time in range" (3.9-10.0 mmol/L) compared to insulin glargine U100 in patients with type 2 diabetes.In patients with type 2 diabetes who have not previously received insulin therapy, the overall incidence of clinically significant hypoglycemia and severe hypoglycemia observed in both the once-weekly basal insulin icodec treatment group and the control group was less than 1 event per patient-year of exposure.Novo Nordisk stated: "We understand the burden that daily injections place on many patients with type 2 diabetes. We remain committed to developing innovative solutions to help people with diabetes manage their blood sugar more freely and effectively while reducing the burden. As the world's first once-weekly basal insulin,Icodec"It is the latest innovative achievement in insulin therapy. By reducing the number of basal insulin injections from 7 times per week to just once, we believe it will have a significant impact on both diabetes patients and healthcare professionals, improving the management model for diabetes treatment."Notably, Eli Lilly also announced this month that its once-weekly insulin Insulin Efsitora Alfa for the treatment of type 2 diabetes obtained positive data from two Phase III studies, QWINT-2 and QWINT-4.Copyright © 2024 PHARMCUBE. All Rights Reserved.
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