Had Novo Nordisk’s insulin icodec secured FDA approval, it would have been the first and only once-weekly basal insulin option for adults with diabetes.
The FDA has issued a Complete Response Letter (CRL) to Novo Nordisk for the company’s once-weekly basal insulin icodec for the treatment of diabetes, the pharmaceutical company announced in a release.1
In the CRL, the agency said it requires additional details on the manufacturing process as well as the drug’s indication for type 1 diabetes (T1D) before it can complete its review of a Biologics License Application. Novo Nordisk said it will not be able to provide this information until next year.
About ONWARDS 6
Trial Name: A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6)
Clinicaltrials.gov Identifier: NCT04848480
Sponsor: Novo Nordisk A/S
Summary: The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily.
“We believe in the potential of once-weekly basal insulin icodec for those living with diabetes who require basal insulin therapy,” said Martin Lange, executive vice president for Development at Novo Nordisk, in the release.1 “We will work closely with the FDA to identify the next steps needed to complete the review so we can provide this novel treatment option to adults living with diabetes.”
In April 2023, Novo Nordisk submitted an application for its once-weekly basal insulin icodec. In May 2024, the FDA convened a panel of independent experts to evaluate the drug’s benefit and risks. After review, the panel determined in a 7 to 4 vote that the available data were insufficient to determine whether the advantages of insulin icodec outweighed the potential risks for patients with T1D.2
The panel did not discuss the use of once-weekly insulin icodec for type 2
Data from six phase 3 ONWARDS clinical trials supported Novo Nordisk’s application. The first 5 trials assessed patients with T2D, and the sixth assessed patients with T1D.
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The company presented results of ONWARDS 1 (
The trial compared once-weekly insulin icodec with once-daily insulin glargine U100 in insulin-naïve adults with T2D and inadequate glycemic control.3 Results showed that more insulin-naïve adults with T2D with once-weekly basal insulin icodec achieved target hemoglobin A1c (HbA1c) levels and did not experience clinically significant or severe hypoglycemia at 52 weeks when compared with the insulin glargine group. In the trial, no new safety signals were identified.
ONWARDS 6 (
Despite these outcomes, results from the ONWARDS series fell short of FDA requirements for approval.
Had Novo Nordisk’s insulin icodec secured
In the European Union, Canada, Australia, Japan and Switzerland, insulin icodec is approved under the brand name Awiqli for the treatment of T1D and T2D, and in China for the treatment of T2D.
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