USA – The U.S. FDA staff raised concerns regarding the use of Novo Nordisk’s long-acting weekly Insulin, citing an elevated risk of low blood sugar in patients with type 1 diabetes.
This warning is especially pertinent for those who are more dependent on Insulin.
Novo Nordisk is endeavoring to introduce the first weekly insulin product to the market, offering an alternative to the daily insulin injections that millions of patients with type 1 diabetes, as well as those with type 2 diabetes, currently rely on.
The company has suggested incorporating continuous glucose monitoring devices into the label’s recommendations for type 1 diabetes patients to monitor blood sugar levels, among other measures, as indicated by FDA reviewers.
However, FDA staff have expressed reservations about Novo’s proposed methods for mitigating the risks associated with hypoglycemia, emphasizing the need for clinical data supporting these approaches.
Hypoglycemia occurs when blood sugar levels plummet below the standard range.
Novo Nordisk conducted six late-stage trials involving over 4,000 adults with diabetes to evaluate its weekly insulin icodec, with only one trial specifically focusing on patients with type 1 diabetes.
In this trial, type 1 diabetes patients treated with insulin icodec exhibited 50% to 80% more clinically significant or severe hypoglycemia compared to those treated with once-daily insulin degludec, marketed by Novo under the brand name Tresiba.
Richard Siegel, an associate professor at Tufts University School of Medicine, highlighted the heightened risk of hypoglycemia in type 1 diabetes patients and stressed the need for discussions regarding insulin dosage adjustments if blood sugar levels deviate from the target range.
An independent panel of FDA advisers is scheduled to convene to evaluate whether insulin icodec’s benefits outweigh its risks.
While the FDA is not bound to follow the panel’s recommendations, it typically does.
Meanwhile, Novo Nordisk’s competitor, Eli Lilly, is also developing its once-weekly insulin injection, efsitora. In studies involving patients with type 2 diabetes, efsitora has demonstrated blood sugar reduction consistent with commonly used daily Insulin.
On May 24, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will review Novo Nordisk’s application for approval of once-weekly insulin icodec.
The regulatory review was initially extended by three months in December 2023 to allow for a comprehensive submission review. It is expected to conclude in the third quarter of 2024.
In April, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approving the once-weekly injection of icodec based on Phase 3 data. If approved, the drug will be marketed in Europe under the name Awiqli.
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