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 diabetes.
Awiqli is indicated as an adjunct to diet and exercise and is intended to reduce injections from seven per week to one, according to a March 26 news release from Novo Nordisk. The approval is based on data from the ONWARDS phase 3a clinical program, which included four randomized trials with approximately 2,680 adults. Awiqli lowered blood glucose levels more effectively than daily insulin treatments.
Novo Nordisk said the safety profile of the long-acting insulin was consistent with that of the daily basal insulin class and that reported side effects included hypoglycemia, allergic reactions and injection site reactions.
Awiqli will be available nationwide in the coming months, the drugmaker said.
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