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The FDA expanded approval of insulin icodec (Awiqli), making it the first once-weekly insulin indicated for children ages 10 and older with type 2 diabetes. Separately, a U.S. judge denied Novo Nordisk’s request to temporarily stop Eli Lilly from running ads comparing the effectiveness of their weight-loss and diabetes drugs. The source report also notes that the U.S. fertility rate reached a record low in 2025.
The U.S. Food and Drug Administration expanded approval of insulin icodec, sold as Awiqli, to include people ages 10 and older with type 2 diabetes, making it the first once-weekly insulin indicated for this pediatric group, according to an October 27 report. In a separate development, a U.S. judge denied Novo Nordisk’s request to temporarily block Eli Lilly from advertising that its weight-loss and diabetes drugs are more powerful.
The FDA action concerns insulin icodec, a long-acting insulin administered once a week. The expanded indication covers children with type 2 diabetes ages 10 and older. The report identifies Awiqli as the first once-weekly insulin indicated for those patients. It does not provide further details about the FDA’s review, the terms of the approval, or how clinicians are expected to use the medicine in practice.
The advertising dispute involves Novo Nordisk and Eli Lilly, which sell competing medicines for weight loss and diabetes. Reuters, in a report carried by AOL, said the judge rejected Novo Nordisk’s request for a temporary block on Lilly advertisements claiming its drugs are more powerful. The ruling concerns the request for temporary relief; the source summary does not explain the judge’s reasoning or establish whether the companies’ wider legal dispute is resolved.
The same endocrinology roundup also cited CDC data showing that the U.S. fertility rate fell 1% in 2025, to 53.2 births per 1,000 females ages 15 to 44, a record low. That demographic update is separate from the FDA decision and the drug-advertising case, but it was among the health developments highlighted in the report.
Weekly Insulin Reaches Younger Patients
The FDA expansion adds a once-weekly insulin option to the indicated treatments for children at least 10 years old with type 2 diabetes. A weekly schedule differs from more frequent insulin dosing and may affect treatment planning for families and clinicians. The report does not say how widely Awiqli will be prescribed, whether it will be suitable for a particular child, or how it compares with other treatment choices for this age group.
The advertising ruling matters for a different reason: it allows Lilly’s ads to continue for now, despite Novo Nordisk’s effort to halt them temporarily. Claims comparing the strength of competing medicines can shape public understanding and commercial competition. The report provides no details on the evidence behind the advertisements, so the denial should not be read as a judicial finding that the claims are accurate.
The fertility figure offers a separate national measure of births, not an explanation for the change. The reported rate fell to 53.2 births per 1,000 women ages 15 to 44 in 2025. The source does not provide causes or regional breakdowns, limiting what can be concluded from the figure alone.
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Three Developments in One Health Roundup
The October 27 report summarized developments across endocrinology and public health rather than describing one connected event. Alongside the Awiqli approval expansion and the court ruling over Lilly’s advertising, it cited research on diabetes prescribing and GLP-1 use. A cross-sectional study reported that endocrinologists were more likely to prescribe SGLT2 inhibitors and GLP-1 receptor agonists after updates to American Diabetes Association guidelines. A separate retrospective cohort study suggested that GLP-1 drug use among Medicare beneficiaries with type 2 diabetes rose more than 16-fold from 2010 to 2022, with limited differences by cancer history.
Those studies address prescribing patterns, not the FDA’s decision on pediatric insulin or the legal merits of the advertising claims. The roundup also referenced a Swedish cohort study associating autoimmune disease during pregnancy with a 57% higher risk of type 1 diabetes in offspring. These findings are distinct from the U.S. fertility statistic and do not establish that autoimmune disease explains changes in birth rates.
“A U.S. judge rejected Novo Nordisk’s request to temporarily block Eli Lilly from running advertisements claiming its weight-loss and diabetes drugs are more powerful.”
— Reuters, in a report carried by AOL
Approval and Ad Claims Still Need Detail
The available report does not give the full FDA label, the agency’s detailed rationale, or information on Awiqli’s safety profile and prescribing conditions for children. It also does not describe the clinical evidence or practical guidance accompanying the expanded indication. Families should rely on a child’s diabetes care team for treatment decisions rather than infer suitability from the approval summary alone.
For the advertising case, the judge’s reasoning, the specific wording and evidence in Lilly’s ads, and any further court proceedings are not included. The denial of a temporary block is not, on the information provided, a ruling that the comparative claims have been proven. The fertility-rate summary likewise does not give a detailed methodology, state-level figures, or reasons for the decline.
Watch for FDA and Court Details
Further information to watch for includes the full FDA indication and prescribing information for Awiqli, including any conditions or limitations relevant to children. Clinicians and families can then assess the medicine within individual treatment plans and alongside other available care.
In the advertising dispute, subsequent court filings or rulings could clarify the judge’s reasoning and whether Novo Nordisk pursues additional action. Lilly’s advertisements may continue following the denial of temporary relief, based on the report. The CDC’s fertility data may also be examined in fuller releases with additional demographic detail; the source summary does not specify a release schedule.
Key Questions
What did the FDA approve for children with type 2 diabetes?
The FDA expanded the indication for insulin icodec, marketed as Awiqli, to include people ages 10 and older with type 2 diabetes. The report describes it as the first once-weekly insulin indicated for that group.
Did the judge rule that Eli Lilly’s ads are accurate?
The report says the judge denied Novo Nordisk’s request to temporarily block the advertisements. It does not say the court found the comparative claims accurate or provide the judge’s reasoning.
What fertility rate did the report cite?
CDC data cited in the report put the U.S. rate in 2025 at 53.2 births per 1,000 females ages 15 to 44, down 1% from 2024 and described as a record low.
Are the insulin approval, ad dispute and fertility data connected?
No connection is established in the source. They are separate developments collected in an endocrinology and health news roundup.
Source: rss
