FDA Advisers Vote Against Novo Nordisk's Weekly Insulin for Type 1 Diabetes Due to Risks

During a meeting on Friday, May 24, advisers to the U.S. health regulator voted against the usage of Novo Nordisk's weekly insulin in patients with type 1 diabetes. The panel of independent experts from the Food and Drug Administration voted 7-to-4, stating that the benefits of the weekly insulin icodec do not outweigh the associated risks.

Cecilia Low Wang, the panel chairperson, expressed concerns about approving the insulin icodec for use without adequate data. She emphasized that this might hinder further trials that are necessary to ensure its safe usage in type 1 diabetics. The FDA's staff had previously flagged the risk of low blood sugar in type 1 diabetes patients, who heavily depend on insulin. Additionally, there was a lack of clinical data to support Novo's proposed methods for mitigating the risks associated with hypoglycemia.

Novo's Response and Analyst Insights

Novo Nordisk stated that they will continue working closely with the FDA to determine the next steps required to bring the treatment to the market. Analysts, such as Derren Nathan from Hargreaves Lansdown, highlighted that the increase in hypoglycemic events for type 1 diabetics could pose a barrier for these patients. On the other hand, Barclays analyst Emily Field mentioned the possibility of seeking approval for type 2 diabetes patients, considering it a larger market.

Regulatory Considerations and Market Competition

While the FDA typically follows the recommendations of its expert panel, they are not obligated to do so. It is worth noting that the weekly basal injection, marketed as Awiqli, was recently approved for use in the European Union. This development was announced by the Danish drugmaker on Friday. Basal insulin plays a crucial role in regulating blood glucose levels throughout the day. It differs from bolus insulin, which manages blood glucose rise after meals. Moreover, competitor Eli Lilly is also in the process of developing its own once-weekly insulin injection, called efsitora.