FDA Approves Once-Weekly Basal Insulin Awiqli for Type 2
The FDA has approved Novo Nordisk’s Awiqli (insulin icodec-abae), making it the first once-weekly basal insulin available in the U.S. for adults with type 2. This follows previous approvals from the European Union, Canada, Australia, India, Japan, China, and eight other countries.
The insulin is to be injected using a prefilled pen on the same day each week.
The prescribing information notes that when switching from daily basal insulin, glucose levels need to be monitored closely because dosing is different with Awiqli's long-lasting action, and hypoglycemia remains the most common side effect.
Weekly dosing comes with its own learning curve, and the label makes clear that dose mix-ups and low blood sugar are important concerns. But for anyone with type 2 who has delayed starting basal insulin, struggles to consistently take a daily shot, or just wants a simpler routine, once-weekly insulin could be a better fit.
What the research says
In addition, for the first time, the FDA-approved label includes Time in Range (TIR, 70-180 mg/dl) data, a major milestone in how we measure and communicate glucose management.
Multiple studies have shown that Awiqli produces time-in-range results similar to daily basal insulin. In one trial of adults already using basal insulin, time in range during weeks 22 to 26 was 62.3% with Awiqli and 59.9% with insulin degludec (Tresiba). In a separate trial of adults using long-acting insulin plus mealtime insulin, time in range was 66.8% with Awiqli and 66.5% with insulin glargine (Lantus/Basaglar).
For people who had never used insulin, one study suggested that Awiqli might actually produce even better results than daily basal insulin. In the trial, participants who started on Awiqli spent significantly more time in range (71.9%) during weeks 48 to 52 than those who started on insulin glargine (66.9%). At the same time, Awiqli was associated with bigger drops in A1C values (-1.6%) than insulin glargine (-1.4%).
However, in another trial comparing Awiqli and insulin degludec for people new to insulin, the two drugs both produced similar decreases in A1C values, suggesting that Awiqli is just as effective, not more effective.
In all of these trials, the risk of hypoglycemia was very low, regardless of whether participants were taking daily or weekly insulin. Although there tended to be a slight increase in the rate of hypoglycemic events among people taking Awiqli, the rate of severe events was similar when participants were also given an app that offered dosing guidance.
As of now, the FDA has only approved Awiqli for people with type 2 diabetes, but regulatory agencies in some other countries have also approved it for people with type 1. A trial comparing Awiqli and insulin degludec for people with type 1 diabetes showed that the two medications were similarly effective for blood glucose management, but the FDA’s conclusion of the data was that the increased rates of hypoglycemic events was a bigger safety concern for people with type 1 at this time that outweighed the benefits of once weekly dosing.
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