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PROs In Diabetes: FDA Panel Wanted Data Proving Insulin Icodec’s ‘Theoretical’ Benefits In Type 1

 
• By Sue Sutter

Patient-reported diabetes treatment satisfaction questionnaire used in Novo Nordisk’s ONWARDS 6 study had methodological shortcomings, US FDA said. Without reliable PRO data, benefits from a once-weekly injection remained theoretical, while hypoglycemia risks were real, panelists said.

Once a week
Novo failed to prove the benefits of once-weekly basal insulin dosing. • Source: Shutterstock

US Food and Drug Administration advisory committee members have a message for biopharma sponsors: If you’re going to claim that a reduction in doses improves adherence, you’d better show proof.

Panelists at the recent Endocrinologic and Metabolic Drugs Advisory Committee meeting on Novo Nordisk A/S’s once-weekly insulin icodec found themselves trying to weigh the “clear” risk of hypoglycemia in type1 diabetes with the “theoretical” benefits

Key Takeaways

  • Data from the DTSQ instrument used in the Phase III study were insufficient to draw conclusions about whether patients were more or less satisfied with insulin icodec compared to insulin degludec.

  • Adcomm members said Novo failed to prove the benefits of the once-weekly injection were more than theoretical

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