FDA Panel Rejects Novo Nordisk's Weekly Insulin for Type 1 Diabetes

Novo Nordisk's bid to secure FDA approval for its once-weekly insulin icodec injection for type 1 diabetes faced a setback last Friday. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted against the approval in a 7-4 decision, citing concerns about the elevated risk of hypoglycemia associated with the investigational product.

The panel of external experts compared insulin icodec to Novo Nordisk’s existing daily insulin injection, Tresiba (insulin degludec). They found that while both products aim to control blood glucose levels, insulin icodec posed a higher risk of hypoglycemia. “When compared to the current standard degludec, which has a good safety profile, this was an incremental increase,” noted Matthew Drake, an associate professor of medicine at Mayo Clinic College of Medicine, during the meeting. Drake, who voted against the approval, expressed concerns that the once-weekly injection would require approval with strict conditions, such as mandatory continuous glucose monitoring (CGM). He pointed out that the patients likely to benefit from this new insulin might be the least likely to regularly monitor their blood sugar levels.

On the other hand, Paul Tibbits Jr., a patient representative who voted in favor of the investigational insulin, acknowledged the potential benefits but emphasized the need for significant caveats. He suggested that the product’s label should include a CGM requirement and possibly exclude patients with hypoglycemic unawareness or those in their first year of diabetes. Tibbits Jr. stated, “As a patient representative, I certainly want to help people with diabetes, but I also don’t want to hurt them, and I think this product has the potential to do both.”

Novo Nordisk aims to market insulin icodec, a long-acting insulin analog, as a more convenient option for diabetes patients, offering a once-weekly injection compared to daily insulin products. To support their application for type 1 diabetes, the pharmaceutical company presented data from the ONWARDS 6 trial. The trial data indicated that insulin icodec could achieve glycemic control that was non-inferior to daily basal insulin. However, the once-weekly regimen was associated with a higher risk of "clinically significant" or "severe" hypoglycemic episodes, as mentioned in the briefing documents.

FDA's internal reviewers also highlighted this risk in their assessment. While acknowledging that hypoglycemia is a known side effect of insulin products, they noted that insulin icodec did not offer additional glycemic control or other benefits for type 1 diabetes patients.

Although the FDA often follows the advisory committee's recommendations, it is not obligated to do so. The target date for the FDA's final decision on insulin icodec is set for the third quarter of 2024.

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