Novo Nordisk announced on Thursday that their widely successful weight-loss medication Wegovy might soon receive an expanded approval from the U.S. Food and Drug Administration (FDA) within six months. The company’s Chief Financial Officer, Karsten Munk Knudsen, shared with CNBC that the Danish pharmaceutical firm had applied for priority review to gain approval for Wegovy as a treatment to reduce the risk of cardiovascular disease.
This potential approval from the FDA holds the promise of enhancing insurance coverage for this much sought-after drug. Knudsen expressed confidence during an interview with CNBC’s Julianna Tatelbaum on “Street Signs,” stating that the outcome might be anticipated in less than six months from the present day.
In its third-quarter earnings earlier on Thursday, Novo Nordisk unveiled intentions to seek expanded FDA approval for its obesity drug but refrained from disclosing a specific timeline. The company also revealed record profits and sales during this period, attributing the success to the widespread popularity of its obesity medication.
More health applications
A pivotal aspect of Wegovy’s potential is its application in enhancing health. Notably, late-stage trial data released in August demonstrated Wegovy’s remarkable ability to reduce major cardiovascular risks like heart attacks or strokes by 20%, as compared to a placebo.
Karsten Munk Knudsen highlighted the significance of the “SELECT” trial, emphasizing Wegovy’s substantial impact in decreasing cardiovascular risk among an obese population with established heart disease by 20%. This outcome marked a significant shift in Wegovy’s perception from a mere “vanity drug.”
The encouraging results from the “SELECT” trial acted as a catalyst for Novo Nordisk’s ambitions, expanding beyond Wegovy’s existing market positioning. This positive momentum contributed to the company’s stock soaring by 1.5% on the morning after the earnings report. Notably, throughout the year, the company’s shares have surged by almost 45%.
Knudsen revealed that the company plans to present an elaborate report of the trial findings in about 10 days, after which the FDA will have a six-month window to deliver its decision.
He emphasized that an approval would broaden the drug’s applications, potentially encouraging insurance companies to cover the treatment. Some insurers have hesitated to cover the drug, priced at $1,350 a month in the U.S., exclusively for weight-loss purposes.
“The pricing of the products reflects the value they bring to society,” Knudsen explained, highlighting the significance of generating more data, particularly on conditions like cardiovascular disease or chronic kidney disease. This data contributes to the comprehensive value narrative in discussions with payers and insurers.
Nevertheless, even with approval, challenges in the drug’s supply chain might persist. Knudsen assured that the company is actively escalating Wegovy’s production to address potential shortages.
“Entering the next year, we’re committed to significantly enhancing Wegovy’s supply,” he assured.
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