A panel of advisers to the U.S. Food and Drug Administration (FDA) voted against the approval of Novo Nordisk’s weekly insulin, icodec, for patients with type 1 diabetes due to concerns over low blood sugar risks. The panel, comprising independent experts, voted 7-4, concluding that the benefits of icodec do not outweigh its risks.
Novo Nordisk aims to introduce the first weekly insulin product for both type 1 and type 2 diabetes patients, who currently rely on multiple daily injections. However, panel chairperson Cecilia Low Wang expressed concerns that approving icodec with insufficient data might discourage further necessary trials to ensure its safe use in type 1 diabetes.
The FDA staff had earlier highlighted the increased risk of hypoglycemia and insufficient clinical data supporting Novo’s risk mitigation strategies. Despite the setback, Novo Nordisk announced its intention to continue collaborating with the FDA to determine the next steps for bringing icodec to market.
Analysts suggest that while the FDA may not recommend approval for type 1 diabetes patients, Novo Nordisk could still pursue approval for the larger type 2 diabetes market. The FDA typically follows its panel’s recommendations but is not bound to do so.
As reported by Economic Times, the weekly basal injection, branded as Awiqli, received approval in the European Union earlier this week. Meanwhile, competitor Eli Lilly is developing its own weekly insulin injection, efsitora.