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Staff at the U.S. Food and Drug Administration (FDA) said on Wednesday that Novo Nordisk’s experimental weekly insulin, Awiqli, carried a higher risk of hypoglycemia — low blood sugar — for patients with type 1 diabetes, compared with traditional daily insulin.
Reuters reports that the Danish drugmaker, known for its diabetes and weight loss medications like Ozempic, has proposed a drug label that recommends the use of continuous glucose monitoring devices as a way to mitigate the risk. However, FDA staff said there is no data to support that this would work to reduce the risk of hypoglycemia.
Prolonged hypoglycemia could lead to blurred vision, difficulty concentrating, drowsiness, and in severe cases seizures, according to the American Diabetes Association.
The comments come ahead of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meeting on Friday to review the long-acting insulin.
In March, a European Medicines Agency committee recommended the approval of Awiqli for the treatment of diabetes.
The EMA committee said in a statement that the weekly insulin “will mainly be used in patients with type 2 diabetes, and should only be used in patients with type 1 diabetes for which a clear benefit of a once-weekly administration is expected.”
The committee added that “hypoglycaemic events are more common compared to daily basal insulin” with the use of Awiqli for patients with type 1 diabetes.
Novo Nordisk is racing against its rival Eli Lilly, the maker of competing diabetes and weight loss medications like Zepbound, to introduce a more convenient long-acting insulin to the market.
Last week, Eli Lilly announced positive results of its phase-3 clinical trials for its weekly insulin efsitora. Trial results showed that the long-acting insulin was just as effective as traditional daily doses.