An FDA advisory committee voted 7-4 against Novo Nordisk's experimental weekly insulin shot after a study found elevated hypoglycemia risks and no additional benefits from the candidate.
The therapy, Awiqli (insulin icodec), is intended for diabetic adults and is waiting on FDA approval for Type 1 and Type 2 diabetes. A phase 3 trial comparing the drug candidate to Novo Nordisk's FDA-approved daily insulin product linked Awiqli to higher rates of hypoglycemic episodes. The study focused on Type 1 diabetes.
After about six hours of discussion among FDA panel members, a majority agreed the drug's benefits do not outweigh the risks for improving glycemic control in adults with Type 1 diabetes, adding that more data is needed. The committee did not vote on Type 2 diabetes.
"Novo Nordisk has confidence in the potential of investigational once-weekly basal insulin icodec for those living with diabetes who require basal insulin therapy," a spokesperson told Becker's. "We will continue to work closely with [the] FDA to identify the next steps needed to help provide this novel treatment option for adults living with diabetes."