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Abstract

Novo Nordisk's Awiqli (insulin icodec) is a pioneering once-weekly basal insulin designed to enhance insulin therapy convenience and adherence for people with diabetes. Despite receiving regulatory approval in Canada and the European Union, Awiqli faces hurdles in the United States due to hypoglycemia concerns, particularly for type 1 diabetes patients.

Key Points

• Awiqli Overview: Awiqli is a once-weekly basal insulin developed by Novo Nordisk, aimed at improving glycemic control in diabetes patients.
• Canadian Approval: Health Canada approved Awiqli in March 2024, making it the first once-weekly basal insulin available in the country.
• EU Approval: The European Medicines Agency granted marketing authorization for Awiqli on May 17, 2024, based on its efficacy and safety in clinical trials.
• FDA Concerns: The U.S. FDA has yet to approve Awiqli due to concerns about increased hypoglycemia risk in type 1 diabetes patients.
• Hypoglycemia Risks: Clinical trials indicated higher rates of severe hypoglycemic events in patients using Awiqli compared to daily basal insulins.
• Risk Mitigation Strategies: Novo Nordisk proposed using Awiqli with continuous glucose monitoring and excluding patients with a history of severe hypoglycemia.
• More Data Needed: While Awiqli shows promise for improving diabetes management, further data is needed to address safety concerns for U.S. approval.

Abstract

Eli Lilly’s tirzepatide, known as Mounjaro for type 2 diabetes and Zepbound for obesity, has shown significant efficacy in treating obstructive sleep apnea (OSA) in the SURMOUNT-OSA trial. This groundbreaking study revealed that tirzepatide not only reduces the severity of OSA but also offers substantial cardiometabolic benefits, potentially transforming the treatment landscape for this common condition.

Key Points

• Tirzepatide Efficacy: Demonstrated up to a 62.8% reduction in OSA severity in the SURMOUNT-OSA trial.
• Dual Benefits: Significant weight loss and improvements in cardiovascular markers alongside OSA treatment.
• Disease Resolution: Nearly half of the participants achieved criteria for disease resolution.
• Broader Implications: Potential FDA approval could make tirzepatide the first pharmaceutical treatment for the underlying causes of OSA.
• GLP-1 Drug Expansion: Highlights the expanding therapeutic scope of GLP-1 drugs, following Wegovy’s label expansion to include cardiovascular risk reduction.