Novo Nordisk's Once-Weekly Insulin Flagged With Risk Of Low Blood Sugar Ahead Of FDA Review [Yahoo! Finance]
Novo Nordisk A/S (NVO)
Last novo nordisk a/s earnings: 2/5 01:31 am
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Source: Yahoo! Finance
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 be
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News
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- Eli Lilly and Novo Nordisk are a 'duopoly' in GLP-1 market [Yahoo! Finance Canada]Yahoo! Finance Canada
- Earnings Growth & Price Strength Make Novo Nordisk (NVO) a Stock to Watch [Yahoo! Finance]Yahoo! Finance
NVO
Earnings
- 5/3/24 - Beat
NVO
Sec Filings
- 6/10/24 - Form 6-K
- 6/3/24 - Form 6-K
- 5/28/24 - Form 6-K
- NVO's page on the SEC website