NVO - Novo Nordisk's Once-Weekly Insulin Flagged With Risk Of Low Blood Sugar Ahead Of FDA Review | Benzinga
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 ...