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

31 May 2024

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...