The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted against recommending approval for insulin icodec, a once-weekly insulin for adults with type 1 diabetes. Concerns were raised about the risk of hypoglycemia and the lack of data on risk mitigation strategies. The committee members who voted against the drug cited data showing higher rates of hypoglycemia with insulin icodec compared to another insulin. Despite some potential benefits of weekly administration, such as improved convenience, the increased risk of hypoglycemia outweighed the minimal benefits for adults with type 1 diabetes. Novo Nordisk proposed mitigation strategies, but more data were requested to assess their effectiveness.
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FDA committee rejects recommending once-weekly insulin for approval in type 1 diabetes
