On Thursday (November 2nd) local time, executives from Danish pharmaceutical giant Novo Nordisk stated that their developed heavyweight weight weight loss drug "Wegovy" may receive approval from the US Food and Drug Administration (FDA) to expand its indications in the next six months.
Thanks to Wegovy's huge success in the weight loss field, the company announced record sales and operating profit in its Q3 performance report earlier this day, both exceeding market expectations. The financial report also announced plans to expand drug indications, but did not disclose a specific timeline.
Source: Novo Nordisk official website
Novo Nordisk Chief Financial Officer Karsten Munk Knudsen told the media that the company received a "priority review" from the FDA when applying for a treatment drug to reduce the risk of cardiovascular disease for Wegovy. Priority review means that regulatory agencies are expected to accelerate the review and approval process of drug plans.
If approved by the FDA in the future, Wegovy will have a wider range of programs applicable to US healthcare insurance, and pharmaceutical company Novo Nordisk is expected to generate more revenue. Knudsen said, "I want to say that starting today, it won't take six months to wait for this result
According to an August report by Cailian News Agency, the positive results of Novo Nordisk's highly anticipated phase III trial "SELECT" exceeded expectations, indicating the potential role of Wegovy in reducing the risk of severe cardiovascular disease.
It is understood that SELECT is a randomized, double-blind, parallel group, placebo-controlled phase III trial. The results showed that compared to placebo, patients receiving 2.4 milligrams of smectide showed a statistically significant and superior reduction of 20% in the main objective of major adverse cardiovascular events (MACE).
This number is even much higher than the positive range of 15% to 17% expected by investors and analysts. Within the day, Knudsen also responded by saying, "Can Wegovy reduce the risk of cardiovascular disease? The answer is yes, it has increased by 20%
Knudsen stated that Novo Nordisk will submit a detailed copy of the test results within approximately 10 days, after which the FDA will have 6 months to make a decision. He added that FDA approval will increase the opportunity for insurance companies to pay for this treatment.
According to media reports, Wegovy, which is used for weight loss, is priced at $1350 per month in the United States, which makes some insurance companies unwilling to contract the drug. Knudsen stated that if there is more data on indications, it will be beneficial for Novo Nordisk to negotiate with insurance companies.
In August of this year, Martin Holst Lange, Executive Vice President of Global Development at Novo Nordisk, mentioned plans to conduct more research on children in the "near future". The company also announced last month that Wegovy has a positive effect in delaying renal failure in patients with diabetes.
It is worth mentioning that the company previously had a fixed but constantly updated graph in many public materials, which is the systematic expansion of GLP-1 in new indications, focusing on the liver, brain, intestines, and pancreas, with Smegglutide incorporating multiple major indications one by one.
However, even if Wegovy is approved, supply shortages may continue to hinder the promotion of the drug. Knudsen stated that Novo Nordisk is continuously increasing production, "I can assure you that we will significantly increase Wegovy's supply next year
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