FDA advisors not convinced once-weekly insulin is safe in type 1 diabetes

Key Takeaways

• An FDA advisory committee mostly agreed that an investigational once-weekly insulin product carries too much risk for adults with type 1 diabetes to recommend approval.
• While the FDA isn’t required to follow its advisory committees’ recommendations, it typically does.

An FDA advisory committee mostly agreed that an investigational once-weekly insulin product carries too much risk for adults with type 1 diabetes to recommend approval in this population. In a 7-4 vote, the Endocrinologic and Metabolic Drugs Advisory Committee said that Novo Nordisk had not demonstrated that the benefits of its long-acting insulin icodec (proposed brand name Awiqli) outweighed the risks of hypoglycemia (low blood sugar) for adults with type 1 diabetes. (Though not discussed at the meeting, the product is also under review for adults with type 2 diabetes.)

“The risks are very clear, and the benefits are not,” said Jill Crandall, MD, of Albert Einstein College of Medicine in New York City. “The fact that we didn’t see any actual benefit demonstrated relative to the comparator in the trial was important to me,” added Erica Brittain, PhD, of the National Institutes of Health in Bethesda, Maryland, who also voted against the product.

If approved, Novo Nordisk’s insulin icodec would be the first basal insulin product for weekly dosing, as all other products on the market are designed for daily dosing. While the FDA isn’t required to follow its advisory committees’ recommendations, it typically does.

Edited by Miriam Kaplan, PhD

Source: Kristen Monaco, MedPage Today, May 24, 2024; see source article