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FDA Issues CRL to Novo Nordisk for Once-Weekly Insulin Icodec
The agency is concerned about manufacturing processes involved in production and about the proposed indication for adults with type 1 diabetes.
Novo Nordisk announced on Wednesday that the company had received a complete response letter (CRL) from the FDA covering the company’s Biologics License Application (BLA) for its investigational once-weekly insulin icodec for the treatment of diabetes.1
In the CRL the agency requests additional data on the manufacturing process used to produce the drug as well as the specific indication for type 1 diabetes (T1D). The company said that it is reviewing the letter’s content and will work closely with the FDA to meet the agency’s requests. The company “does not expect to be able to fulfil the requests during 2024,” according to the press statement.1
“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 statement. “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.’’1
Novo Nordisk initiated the pursuit for approval of the novel once-weekly insulin formulation last year with a BLA submission to the US FDA in April and simultaneously to regulatory officials in the EU and China with data assembled from the phase 3 ONWARDS clinical development program, comprised of 6 trials and enrolling 4000 adults with T1D.1 An FDA Endocrinologic and Metabolic Drugs advisory committee meeting in May 2024 concluded with the determination that the data available were insufficient to support a positive benefit-risk ratio of insulin icodec in T1D.1 The vote by the panel of independent experts was 7-to-4 against recommending approval.2
Premeeting briefing documents revealed the agency had flagged a higher risk of hypoglycemia in the ONWARDS 6 trial3 that compared weekly insulin icodec with Novo Nordisk's daily insulin degludec. The agency also pointed to a paucity of mitigation strategies to reduce the risk.2 Study data showed icodec to be noninferior to degludec for reducing hyperglycemia, but that the former was associated with between 48% and 89% more severe hypoglycemia by study week 26.4
There was no discussion of the use of insulin icodec in adults with type 2 diabetes.2
Insulin icodec is approved in the EU, Canada, Australia, Japan, and Switzerland under the brand name Awiqli, for treatment of T1D and T2D. Chinese regulatory authorities have approved the formulation for T2D.1
