Novo Nordisk targets FDA approval for once-weekly insulin after Phase III data

Novo Nordisk has recently completed its six-part ONWARDS Phase III trial, as ONWARDS 5 reached its primary endpoint with Icodec demonstrating non-inferiority in reducing hemoglobin A1C (HbA1c) in patients with type 2 diabetes (T2D) at week 52 in comparison to once-daily basal insulin analogs.

This successful outcome for insulin icodec increases the likelihood of achieving Food and Drug Administration (FDA) approval next year, which will establish Novo Nordisk’s dominance in the basal insulin market with the first once-weekly basal insulin therapy. Over the past several years, Novo Nordisk had several key drug launches in the T2D market, with the glucagon-like peptide-1 receptor agonist (GLP-1RA) Ozempic (semaglutide) and its oral form Rybelsus gaining significant market share in the GLP-1 space. The launch of insulin icodec will undoubtedly ensure their lead in the insulin market, with likely improvements in patient compliance due to insulin icodec’s once-weekly administration and improved glycemic control. Key opinion leaders (KOLs) interviewed by GlobalData have expressed significant interest in the therapy, as it is likely to improve adherence, quality of life and glycemic control for many of their patients. KOLs also keenly anticipate the arrival of icosema, the icodec and semaglutide combination therapy that is currently in Phase III. 

Insulin icodec has achieved significant results in all of its clinical trials (ONWARDS 1, 2, 3, 4 and 6), and with the successful result of part five (ONWARDS 5), Novo Nordisk has demonstrated that icodec can address some of the major issues of the once-daily basal insulin analogs, such as its own insulin Tresiba. Patients had an overall baseline HbA1c of 8.9% and were observed to have a superior HbA1c reduction of 1.68%, compared with a reduction of 1.31% in 1,085 insulin-naive patients who received once-daily basal insulin (insulin degludec or glargine U100/U300). Additionally, there were few trial visits in comparison to the other ONWARDS Phase III trials and icodec was used in combination with Novo Nordisk’s dosing app, which provides a guide to titration. There were no statistically significant differences in the rates of severe or clinically significant hypoglycemia (measured at blood glucose below 3mmol/L), with 0.19 events per patient-year exposed to the insulin icodec and 0.14 events per patient-year exposed to the once-daily basal insulins. Throughout the trial, insulin icodec was observed to have a safe and well-tolerated profile. 

Following its successful Phase III trial, Novo Nordisk is expected to file for regulatory approval for once-weekly insulin icodec across the US, EU and China in H1 2023. GlobalData forecasts that icodec will begin to capture the basal insulin market by H1 2024, with a significant market share obtained from then onward, as its only likely serious competitor is Eli Lilly’s once-weekly Basal insulin- FC, which is currently in Phase III.