A single injection. Once a week. That’s the new reality for millions of adults in the United States managing type 2 diabetes, after the FDA approved icodec-abae — sold under the brand name Awiqli — as the first once-weekly basal insulin available in the country. For people who previously needed a daily injection, that’s a drop from 365 shots a year to just 52.
At a glance
- Once-weekly insulin: Awiqli (icodec-abae, 700 units/mL) is manufactured by Novo Nordisk and is now approved by the FDA for adults with type 2 diabetes.
- Clinical trial results: Data from four phase 3 ONWARDS trials covering 2,680 adults showed once-weekly icodec matched or outperformed daily basal insulin in lowering blood glucose.
- Global approval: The drug had already been approved in the E.U. and 13 other countries — including Canada, Australia, and Japan — before receiving U.S. clearance.
Why this matters for adherence
Insulin adherence is one of the most persistent challenges in managing type 2 diabetes. Daily injections are easy to miss, especially for people juggling work, caregiving, or limited access to healthcare. A weekly regimen removes much of that friction.
Independent industry consultant Charles Alexander, MD, called the approval “a convenient regimen for those with type 2 diabetes who need insulin, especially for those who are also taking a once-weekly GLP-1 or dual receptor agonist.” The logic is practical: if a patient is already injecting a weekly GLP-1 medication, pairing it with a weekly insulin means fewer total injection days — and fewer opportunities to fall off schedule.
Novo Nordisk says Awiqli will be available nationwide in the U.S. in the coming months.
The clinical evidence
The FDA’s approval rests on the four phase 3 ONWARDS trials, which compared once-weekly icodec against daily basal insulin in adults with type 2 diabetes not well controlled by other agents. Participants in the trials used icodec alongside mealtime insulin, a GLP-1 receptor agonist, or oral glucose-lowering drugs. All four trials showed icodec was either noninferior or superior to daily insulin in reducing blood glucose levels.
The path to U.S. approval wasn’t straightforward. The FDA issued Novo Nordisk a complete response letter in July 2024 C.E. after concerns emerged about hypoglycemia risk in people with type 1 diabetes. An FDA advisory panel had voted against approving icodec for type 1 diabetes in May 2024 C.E. — while expressing no safety concerns about its use in type 2. Novo Nordisk ultimately refocused its application on type 2 diabetes, where its data was strongest.
Real-world cautions
No treatment is one-size-fits-all, and clinicians are already thinking carefully about who is the best fit for once-weekly insulin.
Anne L. Peters, MD, professor of clinical medicine at the University of Southern California, Los Angeles, is cautiously optimistic. “I’m actually eager to have it as part of my armamentarium, but it’s got to be individualized,” she told Medscape Medical News. She sees clear benefits for patients who are relatively sedentary, where consistent dosing aligns well with stable insulin needs. But she notes that patients whose activity levels vary week to week — or who might experience sudden changes in mobility, like a broken hip — could face challenges because the drug’s long-acting profile makes it hard to adjust quickly.
Some trials also showed numerically higher rates of hypoglycemia with icodec compared to daily glargine, though the difference was not statistically significant. Peters recommends that patients starting once-weekly insulin receive education about hypoglycemia signs and, ideally, use continuous glucose monitors.
Cost and insurance coverage are real barriers. Peters raised concerns that patients who struggle most with adherence — and who would benefit most from a weekly regimen — are often those least likely to afford a newer, more expensive drug. Access issues already affect weekly GLP-1 medications in some U.S. states, and similar patterns could emerge with Awiqli under Medicaid.
What comes next
Eli Lilly is also developing a once-weekly basal insulin analog called efsitora alfa, meaning competition in this emerging category may expand patient options and, potentially, bring prices down over time.
For now, the FDA’s approval of Awiqli marks a meaningful shift in how type 2 diabetes can be managed — one that puts convenience and consistency more firmly within reach for a large share of the estimated 38 million Americans living with diabetes. The ONWARDS 1 trial results, published in the New England Journal of Medicine, and the broader FDA novel drug approval record both speak to how seriously regulators and researchers are taking long-acting insulin innovation. The International Diabetes Federation estimates that more than 500 million adults worldwide live with diabetes — making treatments that improve adherence a genuinely global priority.
Read more
For more on this story, see: Medscape Medical News
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