Flagging a risk of hypoglycemia, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Friday did not recommend the approval of Novo Nordisk’s once-weekly insulin icodec for type 1 diabetes.
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.
In a 7-4 vote, the panel of external experts found that insulin icodec’s benefits do not outweigh its risks. The FDA’s advisers flagged the elevated risk of hypoglycemia associated with the investigational once-weekly insulin, compared to Novo’s daily injection Tresiba (insulin degludec).
“When compared to the current standard degludec, which has a good safety profile … this was an incremental increase,” Matthew Drake, associate professor of medicine at Mayo Clinic College of Medicine, said during the meeting.
Drake, who voted against icodec, added that he was concerned that the once-weekly injection would need to be approved “with contingencies,” such as the specific need for continuous glucose monitoring (CGM). “The patients who may be most likely to benefit from this … are unfortunately the ones tend to be the least likely to actually monitor their blood sugar with some regularity.”
Paul Tibbits Jr., a patient representative who voted in favor of insulin icodec, said that he agreed that the investigational injection was “approvable” but only with “significant caveats,” such as the inclusion of a CGM requirement on its label, excluding patients “who have hypoglycemic unawareness” and potentially disallowing the use of the drug in patients who are in their first year of diabetes.
These limitations would be “some of the more draconian limitations the FDA could put” on a product, Tibbits Jr. said. “As a patient representative, I certainly want to help people with diabetes, but I also don’t want to hurt them, and I think this product has the potential to do both.”
Novo Nordisk is seeking approval for insulin icodec, a long-acting analog of insulin, to help boost glycemic control in patients with diabetes. Unlike once-daily insulin products, icodec differentiates itself by offering a once-weekly injection option, making it more convenient for patients.
To support its type 1 diabetes approval bid, the pharma provided data from the ONWARDS 6 trial, which showed that insulin icodec could elicit glycemic control that was non-inferior to daily basal insulin. However, the investigational once-weekly regimen led to a higher risk of “clinically significant” or “severe” hypoglycemic episodes, according to its briefing document.
The FDA’s internal reviewers flagged this risk, noting in its briefing document that while hypoglycemia is an expected side effect of insulin products, icodec did not yield “additional glycemic control or other benefit” in type 1 diabetes patients.
The FDA is not required to follow the advisory committee’s recommendation, though it often does. Its target action date for insulin icodec is in the third quarter of 2024.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
