Novo Nordisk A/S’s once-weekly human insulin analogue for adults with type 1 diabetes mellitus could be a useful tool for patients and physicians, the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee said May 24, but it also agreed that the risks outweighed the benefits for improving glycemic control.
Once-daily insulin treatment is getting a challenge from Novo Nordisk A/S’s once-weekly option. The U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meets Friday, May 23, to review the BLA for once-weekly Awiqli (insulin icodec), a human insulin analogue from Novo for adults with type 1 diabetes mellitus.
As a meeting looms of the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee to evaluate a similar product from Novo Nordisk A/S, Eli Lilly and Co. made public positive top-line phase III data with its once-weekly insulin, efsitora alfa, in adults with type 2 diabetes using insulin for the first time and in those who require multiple daily injections.
