FDA advisers weigh benefits of weekly insulin for people with diabetes
Will Weekly Insulin Change Diabetes Care?
FDA advisers are currently assessing the benefits versus risks of Novo Nordisk's once-weekly insulin icodec for type 1 diabetes, with the committee divided in their opinions. If approved, it would be the first weekly insulin treatment in the U.S. The main concern is the higher incidence of significant hypoglycemia compared to daily insulin degludec, despite better glucose level reduction. The FDA will consider the committee's insights but isn't bound by their recommendation.
What were the main safety concerns associated with insulin icodec mentioned during the FDA advisory committee's discussions?
The main safety concern associated with insulin icodec mentioned during the FDA advisory committee's discussions was the higher incidence of hypoglycemia, also known as low blood glucose, compared with insulin degludec. Hypoglycemia can lead to a loss of consciousness or seizures. The committee's meeting materials stated that "insulin icodec was associated with 50 to 80% more clinically significant or severe hypoglycemia compared to insulin degludec at Week 52, depending on the method of analysis."