An advisory panel set up by the U.S. Food and Drug Administration (FDA) voted against allowing the use of Novo Nordisk’s weekly insulin product among type 1 diabetic patients as the benefits failed to outweigh the risks.
The objective of the FDA advisory committee meeting was to discuss the safety and efficacy of insulin icodec among people with type 1 diabetes. The 11-member committee voted in a 7–4 tally to rule that the benefits of insulin icodec do not outweigh the risks for improving glycemic control. An FDA briefing document submitted to the committee outlined the agency’s findings about the product.
Novo Nordisk conducted a phase 3 trial of the product with type 1 diabetes patients. The trial showed that “the rate of hypoglycemic episodes was significantly higher” among those who took insulin icodec compared to another product “insulin degludec.” Hypoglycemia occurs when the level of sugar in the blood drops below the healthy level.
The condition is common among people with diabetes, especially type 1. For most diabetics, hypoglycemia is said to occur when the blood sugar level drops below 70 milligrams per deciliter. The condition requires immediate consumption of sugar or carbohydrates.
Severe hypoglycemia can be fatal, potentially requiring emergency medical intervention. The FDA document pointed out that the trial data showed Novo Nordisk’s insulin icodec caused excess hypoglycemia while showing no evidence of any additional glycemic control or othe.
