FDA Issues CRL for Once-Weekly Insulin for Type 1 Diabetes


The FDA is asking for information about the manufacturing process, as well as the type 1 diabetes indication.

FDA has issued a complete response letter for Novo Nordisk’s biologics license application for the once-weekly basal insulin icodec to treat patients with diabetes. The FDA is asking for information about the manufacturing process, as well as the type 1 diabetes indication.

In a news release, Martin Lange, executive vice president for Development at Novo Nordisk. The company will work closely with the FDA to identify the next steps needed to complete the review.

Type 1 diabetes is an autoimmune disease that affects about 2 million Americans, about 5% to 10% of all diabetes cases, according to the Centers for Disease Control and Prevention (CDC).

In the United States, about one-third of patients with type 1 diabetes are managed with multiple daily insulin injections, but adherence is about 53%.

Insulin icodec as a long-acting insulin analog intended for once weekly subcutaneous injection.

Novo Nordisk submitted the application to the FDA in April 2023. In May 2024, an FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting was convened with a panel of independent scientific experts to discuss the benefit-risk of once-weekly basal insulin icodec in type 1 diabetes. The panel determined that the data available were not sufficient to conclude on a positive benefit-risk in type 1 diabetes. The advisory committee did not discuss the use of once-weekly insulin icodec in type 2 diabetes.

Novo Nordisk’s application was based on data from the ONWARDS clinical trial program. In type 1 diabetes, the phase 3 ONWARDS 6 evaluated insulin icodec in 4,625 patients and results were published in The Lancet in October 2023. The study compared insulin icodec with once-daily degludec in a non-inferiority study. Degludec is a long-acting insulin marketed as Tresiba by Novo Nordisk.

The study found that in adults with type 1 diabetes, once-weekly icodec showed non-inferiority to once-daily degludec in HbA1c reduction at week 26.

In a briefing document ahead of the advisory committee meeting, the FDA indicated that the rate of hypoglycemic episodes was significantly higher in the insulin icodec arm compared with the insulin degludec arm. The FDA also said patient data collected as part of the trial did not indicate whether they preferred the weekly insulin.

Mathew T. Drake, M.D., Ph.D.

Mathew T. Drake, M.D., Ph.D.

Of those who voted no at the meeting, Matthew T. Drake, M.D., Ph.D., associate professor of medicine, Division of Endocrinology at the Mayo Clinic College of Medicine, said “when compared with the gold standard of degludec, which has a good safety profile, this was an incremental increase. I am concerned that this would need to be approved with contingencies for CGM monitoring,” he said. “In my practice, the patients most likely to benefit are the ones who are least likely to monitor their blood sugar.”

Insulin icodec is approved under the brand name Awiqli in the European Union, Canada, Australia, Japan and Switzerland to treat patients with both type 1 and type 2 diabetes and in China to treat patients with type 2 diabetes.

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