FDA Denies Novo’s Weekly Insulin Over Manufacturing Issues

The FDA has denied approval for Novo Nordisk’s once-weekly insulin icodec injection intended for diabetes management. This decision was communicated via a Complete Response Letter from the regulator, which contained requests related to the drug’s manufacturing process. Concerns were also raised about the use of insulin icodec in treating type 1 diabetes (T1D). Novo Nordisk has indicated that it will not be able to address these requests within the current year.

Martin Lange, Novo Nordisk’s Executive Vice President for Development, stated that the company plans to work closely with the FDA to outline subsequent steps. Lange expressed confidence in the potential of the once-weekly basal insulin icodec for diabetes patients requiring basal insulin therapy.

The FDA's decision follows a previous vote against the approval of icodec by the Endocrinologic and Metabolic Drugs Advisory Committee in May 2024. The committee voted 7-4, indicating that the benefits of icodec do not outweigh its risks based on current evidence. A major point of concern was the increased risk of hypoglycemia in T1D patients compared to the once-daily insulin degludec, known as Tresiba.

The FDA’s internal reviewers had similarly flagged these risks in their briefing document prior to the advisory committee meeting. The document highlighted that while hypoglycemia is a common side effect of insulin treatments, the once-weekly injection of icodec did not show additional benefits in glycemic control or other areas when compared to active comparators. Furthermore, the briefing document indicated that Novo Nordisk did not provide sufficient evidence that T1D patients would prefer once-weekly dosing over daily injections.

Novo Nordisk submitted its application for insulin icodec in April 2023, supported by data from the ONWARDS clinical development program. This program included six Phase III trials, five of which focused on type 2 diabetes, and only one included T1D patients. The data from these studies showed that icodec performed well in type 2 diabetes patients, being non-inferior to daily basal insulin in terms of HbA1c control, with hypoglycemia being relatively rare. However, in T1D patients, while icodec was still non-inferior to daily injections, there was a higher risk of significant or severe hypoglycemic episodes.

To address these issues, Novo Nordisk has proposed including the hypoglycemia risk in the icodec's label and restricting its use to patients who are equipped with continuous glucose monitoring devices.

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