01:43 PM EDT, 05/22/2024 (MT Newswires) -- Novo Nordisk's ( NVO ) insulin icodec for diabetes patients has an increased risk of causing low blood sugar levels, the US Food and Drug Administration said in a briefing document.

"The highest risk period for hypoglycemia with insulin icodec coincides with its peak glucose-lowering effect which occurs on days 2 to 4 following each weekly injection," the report said, citing Onwards 6 trial. "There were also more hypoglycemia-related serious adverse events reported among patients randomized to insulin icodec compared to insulin degludec."

The document will be presented at the Endocrinologic and Metabolic Drugs Advisory Committee meeting Friday when it will consider Novo's application for the ultralong-acting basal insulin analogue. The committee will discuss whether icodec benefits outweigh its risks for the proposed indication to improve glycemic control in adult patients with diabetes mellitus.

In March, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended marketing authorization for insulin icodec for treating diabetes in adult patients.

Novo did not immediately respond to MT Newswires' request for comment.

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