Novo Nordisk’s injectable GLP-1RA sales may increase upon imminent label expansion, says GlobalData

Novo Nordisk recently announced that its FLOW trial, which studies Ozempic (semaglutide) in diabetic patients with chronic kidney disease (CKD), will come to a halt almost one year prior to the planned completion date, as interim results alone were sufficient in proving that the treatment was successful in treating kidney failure in this patient group. However, Novo Nordisk will remain blinded to the data until the trial reaches its formal completion date. The company already has a strong presence in the type 2 diabetes (T2D) and obesity markets. Consequently, the results of Novo Nordisk’s promising FLOW trial may bolster the sales of its subcutaneous glucagon-like peptide-1 receptor agonist (GLP-1 RA) across these indications and other prospective treatment areas, says GlobalData, a leading data and analytics company.

GlobalData’s latest report  “Obesity: Seven-Market Drug Forecast and Market Analysis”, which explores marketed and late-stage pipeline pharmacotherapies in the obesity space, reveals that in the US, Wegovy (semaglutide) (indicated for obesity), and Ozempic (semaglutide) (indicated for T2D and prescribed off-label for obesity) are forecast to reach sales of $8.1 billion and $2.1 billion by 2031, respectively.

Additionally, in GlobalData’s “Type 2 Diabetes: Nine-Market Drug Forecast and Market Analysis – Update” report, Ozempic is forecast to reach sales of $11.4 billion by the end of the forecast period, in 2029.

The FLOW trial compared the effect of Ozempic 1.0mg to placebo as an add-on to the standard of care treatment for CKD, demonstrating that Ozempic would delay CKD progression and lower mortality risk due to kidney and cardiovascular complications. This trial, along with Novo Nordisk’s Phase III SELECT (NCT03574597) trial studying Wegovy in overweight and obese patients with cardiovascular disease (CVD), determined that GLP-1RAs have uses beyond their original purpose in patients with T2D, obesity, or both diseases.

Sara Reci, MSc, Senior Pharma Analyst at GlobalData, comments: “Currently, Novo Nordisk’s Ozempic and Wegovy are marketed for T2D and obesity, respectively. However, Novo Nordisk has indicated that a label expansion is underway to include the use of Wegovy for cardiovascular risk reduction, and judging by the success of the FLOW trial, it may be assumed that Ozempic will have a label expanded to include CKD at some point.”

Nonetheless, despite the promising potential shown by Novo Nordisk’s injectable GLP-1RAs, key opinion leaders (KOLs) do note that the limited supply of semaglutide is one of the major hurdles to drug sales growth.

Reci concludes: “While facilitating a label expansion of Novo Nordisk’s subcutaneous semaglutides is paramount in ensuring that patients with other diseases, namely CKD and cardiovascular disease, receive the best treatment available, it is important to acknowledge that Novo Nordisk has faced manufacturing hurdles, and consequently supply shortages, with semaglutide.

“Nonetheless, if the company’s manufacturing and supply issues are resolved, label expansions may further propel the success of Novo Nordisk’s semaglutide-based therapies across a wider range of indications.”

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