Loading...
Loading...
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to meet on May 24 to review Novo Nordisk A/S’s 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 int.
