Novo Nordisk Resubmits BLA for Once-Weekly Insulin for Type 2 Diabetes

Novo Nordisk has resubmitted its biologics license application (BLA) to the FDA for Awiqli (insulin icodec) injection, a once-weekly basal insulin treatment for adults living with Type 2 diabetes.

About 38 million Americans have diabetes, and about 90% to 95% have Type 2 diabetes, according to the CDC. In Type 2 diabetes, cells don’t respond normally to insulin.

Awigli is a long-acting insulin analog that has been found to have a prolonged half-life of approximately seven days. Icodec binds to a protein in the blood, albumin, to form an inactive depot. It is released from albumin throughout the week. Awigli is injected subcutaneously.

If approved, Awiqli would become the first once-weekly basal insulin available in the United States, providing an alternative to daily basal insulin injections for adults living with type 2 diabetes.

The resubmission is based on results from the ONWARDS Type 2 diabetes phase 3a program. The program is comprised of five active-controlled clinical trials in approximately 4,000 adults with type 2 diabetes. The clinical program evaluated weekly Awiqli vs. daily basal insulin and the primary endpoint in these trials was change in A1C from baseline.

Anna Windle, Ph.D.

“With this resubmission, we’re closer to offering a new insulin treatment option for people living with type 2 diabetes that, if approved, could reduce their yearly basal insulin injections from 365 to 52,” Anna Windle, Ph.D., senior vice president, clinical development, medical and regulatory affairs at Novo Nordisk, said in a news release.

The resubmission comes after the FDA’s complete response from July 2024. Novo Nordisk had submitted the application for Awiqli in April 2023 for use in patients with either Type 1 or Type 2 diabetes.

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 patients with Type 1 diabetes. The advisory committee did not discuss the use of once-weekly insulin icodec in patients with Type 2 diabetes.

A Novo Nordisk spokesperson said the company prioritized the resubmission in adults with Type 2 diabetes to avoid delays. A new trial with patients with Type 1 diabetes is planned. "We remain committed to people living with Type 1 diabetes and see important potential for Awiqli in this community," the spokesperson said.

A previous study, the phase 3 ONWARDS 6, evaluated insulin icodec in 4,625 patients with Type 1 diabetes 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. But regulators were concerned about the rate of hypoglycemic episodes, which was significantly higher in the insulin icodec arm compared with the insulin degludec arm.

Awiqli is approved in 13 countries, including the European Union.