An advisory panel to the US FDA voted 7 to 4 that the benefits of the once-weekly basal insulin analog icodec don’t outweigh the increased risk of hypoglycemia in type 1 diabetes patients. The FDA meeting was specifically for this purpose, based on Novo Nordisk’s ONWARDS-6 trial results. Panelists discussed various risk mitigation strategies for icodec but expressed concerns about its safety compared to current treatments. Despite some panel members voting in favor of the drug, further trials were recommended to determine the patients who could benefit most. Some experts emphasized the importance of technological advancements like automated insulin delivery systems for managing diabetes.
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Advisory Panel Votes Against Once-Weekly Insulin for T1D
