Novo Nordisk aims to file insulin-GLP-1 combo IcoSema this year

Novo Nordisk is pushing forward with plans to seek US approval for IcoSema, a novel combination treatment that merges its once-weekly basal insulin Icodec with the GLP-1 agonist semaglutide. This decision comes shortly after the FDA declined to approve Icodec as a standalone treatment. Novo Nordisk's confidence in IcoSema is bolstered by positive results from the COMBINE 1 trial, which is one of three pivotal Phase III trials assessing the efficacy and safety of the combination treatment.

Martin Holst Lange, Novo Nordisk's head of development, shared during a recent analyst call that the company aims to file for regulatory approval of IcoSema in the latter half of 2024. The combination treatment is also being tested in the ongoing Phase III COMBINE 2 and COMBINE 3 trials, further investigating its potential benefits for patients with type 2 diabetes.

The COMBINE 1 trial specifically assessed the efficacy of once-weekly IcoSema compared to once-weekly Icodec in patients with type 2 diabetes who were not achieving adequate disease control with daily basal insulin. The trial included patients regardless of their use of other oral diabetes medications. IcoSema demonstrated superior efficacy in reducing HbA1c levels, which is a crucial marker of blood sugar control, over a 52-week period.

At the outset, patients had an average HbA1c level of 8.2%. By the end of the study, IcoSema had reduced HbA1c by 1.6 percentage points, compared to a reduction of 0.9 percentage points achieved with Icodec alone. This indicates a significant improvement in glucose control with the combination therapy. Additionally, IcoSema showed more favorable effects on weight management. Patients on IcoSema lost an average of 3.7 kg, while those on Icodec experienced an average weight gain of 1.9 kg. Participants in the study had an initial average body weight of 84.5 kg.

Safety data from the trial were also promising. IcoSema demonstrated a lower rate of clinically significant or severe hypoglycemia, with 0.14 events per patient year, compared to 0.63 events per patient year for Icodec. This suggests that IcoSema not only offers better glucose control and weight management but also poses a lower risk of severe hypoglycemic events.

This progress comes in the wake of the FDA's recent rejection of Icodec as a standalone treatment. The FDA's complete response letter (CRL) requested additional data concerning Icodec's manufacturing process and its application in individuals with type 1 diabetes. Addressing this setback, Lange emphasized that Novo Nordisk is committed to working closely with the FDA to meet their requirements, although the company does not anticipate being able to address these requests within 2024.

Despite this challenge, Novo Nordisk remains optimistic about the potential of IcoSema to meet the needs of patients with type 2 diabetes who require more effective and safer treatment options. The company continues to focus on advancing its clinical programs and preparing for the regulatory submission of IcoSema, with the hope that it will soon become a valuable addition to the therapeutic arsenal against diabetes.