The FDA will decide whether to approve insulin icodec, taking its advisers' discussions into account
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee is divided on Novo Nordisk’s once-weekly insulin icodec for type 1 diabetes due to concerns about increased hypoglycemia despite better glycemic control compared to daily insulin degludec. In a vote, four members supported it while seven opposed. The FDA will consider these recommendations in its approval decision. If approved, guidelines to mitigate hypoglycemia risk will be necessary. Another company, Eli Lilly, is also developing a weekly insulin therapy (PhysSciTech).
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee is divided on Novo Nordisk’s once-weekly insulin icodec for type 1 diabetes due to concerns about increased hypoglycemia despite better glycemic control compared to daily insulin degludec. In a vote, four members supported it while seven opposed. The FDA will consider these recommendations in its approval decision. If approved, guidelines to mitigate hypoglycemia risk will be necessary. Another company, Eli Lilly, is also developing a weekly insulin therapy (PhysSciTech).