Eli Lilly’s weekly insulin injection efsitora alfa secured two late-stage victories on Thursday in a blow to rival Novo Nordisk, which in July failed to secure the FDA’s approval for its basal insulin icodec.
Tag Archive for: icodec
By the end of the year, Novo Nordisk intends to make a regulatory filing for the combination of its icodec and semaglutide, keeping its once-weekly insulin program afloat.
In its Complete Response Letter, the regulator made “requests” related to the drug candidate’s manufacturing process, Novo said in its announcement. The FDA also raised concerns related to the use of insulin icodec in type 1 diabetes (T1D).
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Friday voted against the approval of Novo Nordisk’s once-weekly insulin icodec injection for type 1 diabetes.
The U.S. Food and Drug Administration’s (FDA) staff on Wednesday pointed to “notable imbalance” in incidence of low blood sugar in patients with type 1 diabetes treated with Danish drugmaker Novo Nordisk’s (NOVOb.CO) long-acting weekly insulin.