U.S. approval clears Novo’s weekly insulin for children aged 10 and older
Key Facts
The U.S. Food and Drug Administration listed its approval of Awiqli, or insulin icodec, to treat patients with type 2 diabetes aged 10 and older on October 23, 2026. The drug is used to improve blood sugar control alongside diet and exercise, and is injected under the skin once a week. Novo Nordisk said the weekly option reduces the frequency of basal insulin injections from 7 times a week to once. Awiqli is the first weekly insulin approved by the agency for children with type 2 diabetes. The decision expands the drug’s use after an earlier approval for adults in the same year.
The company says reducing injection frequency offers eligible children a less frequent option, but that does not establish improved treatment adherence. The approval is limited to people with type 2 diabetes aged 10 and older, with Awiqli used as an adjunct to diet and exercise. The agency recorded the decision on October 23, according to its approval records, after having approved the drug for adults earlier in 2026. The timing places the decision within the regulatory expansion of weekly insulin use during the year. In September, the agency listed an approval for another weekly insulin for adults, while the new Awiqli approval applies to children.
The assessment of Awiqli in children drew on a single-dose pharmacokinetic study, which measured drug levels in the blood and included 18 patients. It was not a long-term trial measuring the treatment’s effectiveness in children. Results showed that the first dose was absorbed faster in children than in adults. FDA modeling projected that drug levels in the two groups would become similar after the first doses. The agency also projected that Awiqli would lower blood sugar in children in a way similar to its effect in adults.
The background for Awiqli’s use in adults is the phase 3 ONWARDS program, which included 4 randomized controlled trials and about 2,680 adults. Novo Nordisk said the program showed efficacy in reducing glycated hemoglobin. Those results provide context for the FDA’s expectation of a similar effect in children, but they do not change the nature of the evidence for the new age group, which consisted of a single-dose pharmacokinetic study. The October approval marks the drug’s move from use in adults to children aged 10 and older. The available information did not provide results from a long-term trial of Awiqli’s efficacy in children.
Common side effects listed by the FDA include hypoglycemia, allergic reactions, injection-site reactions, changes in fatty tissue, itching, rash, edema and weight gain. The agency said hypoglycemia is the most common insulin-related effect. It also said the approval application received priority review. This information puts the safety profile and regulatory review among the details of the decision, alongside the drug’s weekly administration. The approval remains directed at patients who meet the specified age and diagnosis criteria.
Novo Nordisk said Awiqli was available in more than 70,000 pharmacies across the United States when it announced the pediatric approval. When announcing the adult approval in March 2026, the company said it expected to launch the drug across the United States in the second half of the year. In trading on October 26, the company’s shares, listed under ticker NVO, closed at $39.13, according to EL7 data. The available information does not compare the closing price with the stock’s movement before or after the approval announcement. The drug’s next step remains tied to its use among the age group covered by the decision, following the company’s rollout through the U.S. pharmacy network.