Awiqli is designed to replace daily basal insulin shots. People with type 2 diabetes take the medication once a week through a disposable prefilled pen.
“This is a huge deal and meets a big unmet need in the diabetes community,” says John Aurora, PharmD, CDCES, a clinical pharmacist and diabetes educator at Tufts Medical Center in Boston.
More than 37 million Americans have diabetes, and over 8 million of those rely on insulin, according to the American Diabetes Association (ADA).
Here’s what you need to know about Awiqli, which drugmaker Novo Nordisk says will be available nationally in the coming months.
Clinical Trial Results Found Awiqli Has Similar Results to Daily Insulin Injections
The FDA approval was based on findings from the ONWARDS type 2 diabetes trial, which consisted of four randomized, controlled trials involving almost 3,000 adults with uncontrolled type 2 diabetes.
Researchers had study participants take Awiqli or daily basal insulin. People in both groups were also taking mealtime insulin and oral diabetes drugs or GLP-1 medication.
The researchers found that people on Awiqli achieved the same blood sugar management as those on daily basal insulin. (This was measured by A1C blood tests measuring average blood sugar levels over the past two to three months.)
The trial found no differences in safety between Awiqli and daily insulin injections. Potential side effects also were similar, including:
- Hypoglycemia (low blood sugar)
- Rare, serious allergic reactions
- Reactions at the injection site
- Skin thickening or pits at the injection site
- Itching
- Rash
- Swelling of the hands and feet
- Weight gain
Awiqli Is Not Approved for Kids or People With Type 1 Diabetes
The FDA did not approve Awiqli for use in children and teens.
Why This FDA Approval Matters, According to Experts
Many people with type 2 diabetes may have a hard time with the scheduling demands and inconvenience of giving themselves basal (long-lasting) insulin, frequently in addition to mealtime (short-acting) insulin.
For these people, Awiqli “may make a difference in terms of quality of life and help with adherence to an insulin regimen,” says Jessica Cording, RD, the author of The Little Book of Game-Changers.
But Cording says it’s “really important” that doctors provide adequate education to patients on how to safely use the weekly injection, as well as alerting patients to potential interactions with other medications and supplements.
Aurora notes that many people with type 2 diabetes are reluctant to make the switch from oral diabetes medications to daily insulin shots when the need arises. But many of these patients are already on a weekly GLP-1 injection, he points out.
“Patients would likely be more willing to add in another weekly injection, allowing us to intensify therapy more quickly versus going months back and forth on whether to start daily insulin injections,” he says.
There Is Another Once-Weekly Insulin Medication in Development
Awiqli may soon have competition; drugmaker Eli Lilly has a once-weekly insulin called efsitora in development.
Multiple phase 3 clinical trials have shown that the medication reduces A1C as well as daily insulin injections and is safe. The company announced in June that it planned to submit the drug to U.S. regulatory agents by the end of 2025.
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