FDA rejects once-weekly basal insulin for diabetes, requests more information
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Key takeaways:
- The FDA is requesting more information on the manufacturing process and type 1 diabetes indication for once-weekly insulin icodec.
- An FDA committee declined to recommend insulin icodec for approval in May.
The FDA declined to approve once-weekly basal insulin icodec for the treatment of diabetes and is requesting more information from Novo Nordisk, according to a company press release.
As Healio previously reported, the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted, 7-4, in May against recommending approval saying that the benefits of insulin icodec (Awiqli, Novo Nordisk) did not outweigh the risks for adults with type 1 diabetes. Some committee members cited higher rates of level two and level three hypoglycemia with insulin icodec compared with once-daily insulin degludec (Tresiba, Novo Nordisk) in the ONWARDS 6 trial as one factor for voting against approval in type 1 diabetes.
In a complete response letter, the FDA requested more information from Novo Nordisk on the manufacturing process and the type 1 diabetes indication for insulin icodec. Novo Nordisk stated in the press release that it is reviewing the content of the complete response letter and will work closely with the FDA to fulfill its requests. Novo Nordisk does not expect to be able to fulfill the FDA’s requests in 2024.
“We believe in the potential of once-weekly basal insulin icodec for those living with diabetes who require basal insulin therapy,” Martin Lange, executive vice president for development at Novo Nordisk, said in the press release. “We will work closely with the FDA to identify the next steps needed to complete the review so we can provide this novel treatment option to adults living with diabetes.”
The FDA committee did not discuss the use of insulin icodec for adults with type 2 diabetes. As Healio previously reported, in the ONWARDS 1 trial, adults with type 2 diabetes had greater improvements in HbA1c and time in range with insulin icodec compared with once-daily insulin glargine U 100 (Lantus, Sanofi).
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