An FDA advisory panel has recommended against the approval of icodec, a once-a-week basal insulin injection for diabetes. The panel concluded that the benefits of the treatment do not outweigh its risks for improving glycemic control in adults with T1D.

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee met today and voted 7 to 4 today against recommending approval. While the FDA is not obligated to follow the panel's advice, it often does so.

This decision comes despite the European Medicines Agency (EMA) committee recommending approval in March and Canada approving its medical use for adults the same month. The EMA had noted that "Insulin icodec 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. In patients with type 1 diabetes, hypoglycemic events are more common compared to daily basal insulin."

Phase 3 randomized, clinical trials found icodec to be safe and effective. However, the FDA panel's vote suggests concerns about the treatment's risk-benefit profile for patients with type 1 diabetes ultimately outweighed the findings of these trials.

Icodec, developed by Novo Nordisk, was intended to be marketed under the tradename Awiqli.