FDA takes time to hear from experts on Novo Nordisk's weekly insulin

30 April 2024
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A once-weekly insulin product developed by Novo Nordisk (NOV: N) will be reviewed by an advisory panel, convened by the US regulator, on May 24.

The update comes around a month after European Medicines Agency (EMA) scientists recommended approval for Awiqli (insulin icodec), for the treatment of diabetes in adults.

The Danish diabetes giant submitted for approval last year, and while a decision was due imminently, the agency extended the review period as a result of more data having been submitted during the review period. The company is seeking approval based on data from the Phase III ONWARDS program.

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