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The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to meet on May 24 to review Novo Nordisk A/S’s (NYSE:NVO) application seeking approval for a once-weekly insulin icodec.
In December 2023, the FDA said that data submitted by Novo Nordisk during the regulatory review is considered to constitute a major amendment to the Biologics License Application (BLA) for insulin icodec.
Therefore, the regulatory review is extended by three months to provide time for a full submission review. Novo Nordisk expects the review to be completed during the third quarter of 2024.
In an FDA briefing document, agency staff said the data showed that long-acting weekly insulin increased the risk of low blood sugar in patients with type 1 diabetes.
The document noted that “the rate of hypoglycemic episodes was significantly higher in the insulin icodec arm compared to the insulin degludec arm.”
Time in Range (TIR) (70 to 180 mg/dL) (%) is a continuous glucose monitoring-based metric that exhibits a moderate correlation with A1C.
In ONWARDS 6, neither treatment arm met the American Diabetes Association (ADA) target of 70% TIR and there was no significant difference between the treatment arms. However, the point estimate for TIR favored insulin degludec.
Novo Nordisk has proposed labeling of insulin icodec to inform about the risk of hypoglycemia, a condition in which blood sugar levels drop below the standard range.
The company has proposed labeling intended to restrict use in type 1 diabetes patients who wear a continuous glucose monitoring device.
The labeling also recommends discontinuation of the product in patients who experience recurring hypoglycemia events.
“No phase 2 study was conducted in patients with T1D to determine the optimal dosing strategy of insulin icodec and bolus insulin to mitigate the fluctuation of plasma glucose concentration,” the document noted.
In April, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approving once-weekly injection of icodec based on Phase 3 data. If approved, the drug would be marketed in Europe as Awiqli.
Price Action: NVO shares are down 0.81% at $134.06 at last check Wednesday.
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Posted In: NVO
