HQ Team
July 11, 2024: Novo Nordisk, has been denied approval for its type 1 diabetic medicine by the USFDA, according to the Danish drugmaker.
The Food and Drug Administration has issued a Complete Response Letter in response to the Bagsværd-headquartered company’s once-weekly basal insulin icodex.
“The FDA has requests related to the manufacturing process and the type 1 diabetes indication before the review of the application can be completed,” according to a Novo Nordisk statement.
The FDA’s complete response letter indicates that the review cycle for an application is complete and that the application is not ready for approval.
The letter explains why the submission was deemed inadequate and often includes the FDA’s recommendations on how the sponsor can address those deficiencies.
Not a rejection
The receipt of a CRL is not a rejection of an application. Instead, it is the method that the FDA uses to provide sponsors with an opportunity to course-correct an application so that it may be approved in a subsequent review.
“Novo Nordisk is evaluating the content of the Complete Response Letter and will work closely with the FDA to fulfil the requests. Novo Nordisk does not expect to be able to fulfil the requests during 2024,” according to the statement.
Insulin icodec is meant for the treatment of diabetes mellitus.
‘Work closely with FDA’
“We believe in the potential of once-weekly basal insulin icodec for those living with diabetes who require basal insulin therapy,” said Martin Lange, executive vice president for Development at Novo Nordisk.
“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’’.
Novo Nordisk applied insulin icodec to the FDA in April 2023.
In May 2024, an FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting was convened with a panel of independent scientific experts to discuss the benefit-risk of once-weekly basal insulin icodec in type 1 diabetes.
The panel determined that the data available were insufficient to conclude a positive benefit-risk in type 1 diabetes.
Type 2 not discussed
The Advisory Committee did not discuss the use of once-weekly insulin icodec in type 2 diabetes.
During the May meeting, the committee voted against recommending insulin icodec to improve glycemic control in type 1 diabetes.
It discussed concerns over hypoglycemia risk and the lack of data on risk mitigation. The Committee voted 7-4, that the benefits of insulin icodec did not outweigh the risks for adults with type 1 diabetes.
Insulin icodec is approved under the brand name Awiqli in the EU, Canada, Australia, Japan and Switzerland for the treatment of both type 1 and type 2 diabetes and in China for the treatment of type 2 diabetes.
