Most diabetes treatments involve daily insulin injections to regulate blood sugar levels. However, Novo Nordisk is seeking FDA approval for a once-weekly insulin injection called insulin icodec, which could become the first of its kind in the U.S. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recently debated whether insulin icodec’s benefits exceed its risks, particularly in type 1 diabetes patients. The vote was split, with four in favor and seven against.
The committee’s evaluation highlighted that insulin icodec might be more effective than the daily insulin degludec in lowering high blood glucose levels but raised concerns due to its association with increased risk of severe hypoglycemia. Hypoglycemia can cause serious effects, including unconsciousness or seizures.
Detailed discussions during the committee meeting suggested that if insulin icodec is approved, guidelines should be established to manage and mitigate hypoglycemia risks. Dr. Barbara Onumah supported the approval, suggesting that while it may not suit everyone, it could be an important addition to treatment options, requiring clear safety guidelines for general use.
On the other hand, Dr. Matthew Drake opposed the approval, favoring insulin degludec due to its proven safety profile. Another committee member, Erica Brittain, acknowledged the potential benefits of fewer injections but was concerned that the trial data did not convincingly show improved glycemic control or adherence, which had been anticipated.
The committee also considered that a weekly injection could simplify the treatment regimen compared to daily doses. Adherence to daily insulin therapies is low, with about 53% of type 1 diabetes patients sticking to their prescribed schedules, and about 22% missing at least one dose over two weeks. Nonadherence can lead to severe diabetic complications.
Meanwhile, Eli Lilly is also developing a weekly insulin treatment for type 2 diabetes, known as insulin efsitora alfa. Their recent Phase 3 trials reported it to be safe and effective for new users and those requiring multiple daily injections, though FDA approval has not yet been sought.
