Novo Nordisk has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration for Awiqli® (insulin icodec), a once-weekly basal insulin injection for adults with type 2 diabetes. If approved, Awiqli® would become the first once-weekly basal insulin available in the United States, offering an alternative to daily injections and reducing the number of basal doses from 365 to just 52 per year.
The decision to focus on the type 2 diabetes indication reflects feedback from the FDA’s Complete Response Letter issued in 2024, which raised concerns about hypoglycemia risk in people with type 1 diabetes and requested additional manufacturing data. The type 2 program, known as ONWARDS, included five phase 3a clinical trials involving approximately 4,000 adults and evaluated changes in A1C compared with daily basal insulin.
Awiqli® is already approved in the European Union and 12 other countries, with further regulatory decisions expected in 2025.
Why Once-Weekly Basal Insulin Starts With Type 2 Diabetes
Novo Nordisk isn’t the only company pursuing once-weekly basal insulin. Eli Lilly is developing its own version, insulin efsitora alfa, and plans to seek regulatory approval for type 2 diabetes in 2025 in the United States, European Union, and Japan. Like Novo Nordisk, Lilly has emphasized that the benefit-risk profile differs in people with type 2 diabetes compared to those with type 1, and it currently has no plans for additional type 1 studies. That approach also reflects a lesson from Novo Nordisk’s experience last year, when an application for type 1 diabetes was rejected over safety concerns. Lilly appears focused on avoiding a similar outcome by starting with the population where once-weekly basal insulin is most likely to succeed.
There’s a clear reason why both Novo Nordisk and Eli Lilly are focusing their once-weekly insulin programs on people with type 2 diabetes first. In trials for type 1 diabetes, once-weekly insulin lowered blood glucose just as well as daily basal insulin, but it also led to more episodes of hypoglycemia (low blood sugar). The risk was highest two to four days after injection, when the insulin’s effect was strongest, and adjusting mealtime insulin doses during that window proved difficult outside of a clinical setting.
For people with type 2 diabetes, the situation is simpler. Many use only basal insulin once a day, and once-weekly options are designed to replace that single daily dose — reducing injections from 365 a year to just 52. Because they don’t require frequent dose adjustments, the risk of hypoglycemia hasn’t been seen at the same level in this population.
In type 1 diabetes, most people also need mealtime insulin, and once-weekly dosing makes that harder to manage. The insulin’s glucose-lowering effect rises and peaks a few days after injection, and if you don’t know exactly where you are on that weekly curve, dosing mealtime insulin accurately becomes much more difficult.
Eli Lilly pointed out this difference with its own once-weekly insulin, efsitora alfa, noting that the benefit-risk profile is not the same in type 1 and type 2 diabetes. Its first regulatory submissions will focus on type 2, the group most likely to benefit now, while approaches for type 1 may take more time.
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Previous Insulin Icodec Coverage
Regulatory Hurdles for Awiqli: Approval in Canada and EU, Concerns in the US
