hapabapa U.S. FDA scientists said that there is a risk that Novo Nordisk's ( NVO ) once-weekly insulin icodec, under investigation for type 1 and type 2 diabetes, can lead to extremely low blood sugar levels.
In briefing documents released Wednesday in advance of a May 24 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting, FDA experts cited data from the ONWARDS 6 trial that showed higher incidence of level 2 and 3 hypoglycemia (clinically significant and severe, respectively) in those on insulin icodec compared to the active comparator, Novo's once-daily Tresiba (insulin degludec) in patients with T1D. The document notes that level 2/3 hypoglycemia events per 100 person-years were 1700 and 916 for the insulin icodec-treated and Tresiba subjects, respectively, by week 52. In addition, it says that Novo came up with three dose-titration scenarios to mitigate the risk of hypoglycemia.
"The results from the mechanistic exposure-response modelling and simulations indicate that the alternative titration schedules for insulin icodec which lowers the risk of hypoglycemia may compromise glycemic control." The reviewers note that Novo ( NVO ) has proposed labeling over the risk of hypoglycemia that includes having those on insulin icodec patients wear a continuous glucose monitoring device and those who repeatedly have hypoglycemia events stop taking the drug. In March, a panel of advisors to the European Medicines Agency recommended approval of insulin icode.
