Risk of Hypoglycemia Trips Once-Weekly Insulin at AdComm

An FDA advisory committee voted 7-4 that the risk of serious hypoglycemia seen with Novo Nordisk’s Awiqli insulin outweighed the convenience of its once-a-week dosing regimen for people with type 1 diabetes.

Once-weekly Awiqli was just as effective as multiple daily shots of insulin degludec, the active comparator in the pivotal phase 3 ONWARDS 6 study. That left members of the Metabolic and Endocrinologic Drugs Advisory Committee to conclude that Awiqli offers no significant advantages over the existing gold-standard therapeutic.

In ONWARDS 6, those taking Awiqli were 80 percent more likely to experience moderate or severe hypoglycemia than those taking insulin degludec. Novo Nordisk acknowledged this imbalance and suggested some postapproval controls that could mitigate it.

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