AdComm Must Weigh Benefit of Once-Weekly Insulin With Risk of Severe Hypoglycemia

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will attempt to balance the benefits of Novo Nordisk’s once-weekly insulin injection Awiqli with an increased risk of moderate and severe hypoglycemia at its May 24 meeting.

Early in the drug’s single phase 3 study, Awiqli appeared just as good as insulin degludec in reducing elevated blood sugar. But later in the study, it lost that edge, becoming not quite as effective as the comparator, while increasing the risk of moderate-severe hypoglycemia by 80 percent.

Novo Nordisk has proposed special labeling to alert patients and doctors to address this risk.

Awiqli snagged a European Medicines Agency recommendation for type 2 diabetes earlier this spring.

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