The U.S. Food and Drug Administration approved Novo Nordisk's weight-loss drug on Monday, giving the Danish drugmaker an upper hand in the market race for powerful oral weight-loss drugs as it seeks to regain lost ground from rival Eli Lilly.
The tablets contain 25 milligrams of semaglutide, the same active ingredient as Wegovy and Ozempic injections, and will be sold under the brand name Wegovy. Novo already sells Libersus, an oral semaglutide for type 2 diabetes.
The approval could be the start of a turnaround for Novo, which has had a tough year that included a drop in stock price, profit warnings and weak sales of its injectable drug Wegovy amid intense competition from Lilly and pressure from combination drugs.
Novo's U.S.-listed shares rose 6% in after-hours trading after the approval announcement.
A late-stage study over 64 weeks showed that participants who took 25 mg of oral semaglutide once a day lost an average of 16.6% of their body weight, while those who took a placebo lost 2.7% of their body weight.
The pill was approved for chronic weight management in adults with obesity or overweight and at least one related health condition, expanding the potential patient base as insurers, employers and governments grapple with rising medical costs related to obesity.
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It could help open the door to tens of millions of untapped patients in a global market expected to be worth about $150 billion annually by the next decade.
“As new indications are developed and oral formulations come to market, the patient base will grow significantly,” said Anand Iyer, chief AI officer at telemedicine company Welldoc.
Novo is using the pill's first-to-market advantage to jump-start sales in the U.S., where it has lost ground to Lilly. Lilly's next-generation weight loss drug, Folglipron, could be approved as early as late March.
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David Moore, executive vice president of Novo's U.S. operations, said taking a pill daily could increase interest and uptake of the drug. Novo manufactures the tablets in North Carolina, US, and has been increasing supply of the tablets “for some time” to ensure “sufficient supply,” he said.
According to a poll released last month by the health policy research institute KFF, about 40% of U.S. adults are obese and about 12% say they are currently taking GLP-1 drugs, according to U.S. government data.
Although Novo had an early market advantage in injectables, it initially struggled to meet explosive demand. Ultimately, Lilly edged ahead of rival Zepbound and now ranks first in weekly prescriptions in the United States.
Novo and analysts say the weight-loss drug will address hesitancy and expand access to shots.
Analysts say the pill could capture about a fifth of the market share by 2030, especially among patients who prefer simpler, less invasive treatment options.
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