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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 icodec.
If insulin icodec is approved, it could compete against Eli Lilly’s (LLY) experimental once-weekly insulin, efsitora. The drugmaker recently reported that the drug met its goals in two phase 3 trials.
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