Novo Nordisk’s Weekly Insulin Rejected by FDA

The The Food and Drug Administration (FDA) has rejected Novo Nordisk’s weekly insulin for treating diabetes, a rare setback for the pharmaceutical giant.

The agency has requests related to the manufacturing process and use of insulin specifically in patients with type 1 diabetes, Novo said in a statement WednesdayThe company, which had submitted an application for the drug for patients with type 1 and type 2 diabetes, said it did not expect to be able to meet applications this year.

The move comes after the FDA convened a panel of advisers in May to discuss the drug, called icodec. The panel voted against approval in patients with type 1 diabetes, raising concerns about the risk of dangerous hypoglycemia in that population.

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