U.S. regulators have given the green light to a tablet version of the weight-loss drug Wegovy, one of the market leaders, making it the first daily oral medication approved for the treatment of obesity.
Approval by the U.S. Food and Drug Administration (FDA), announced on Monday, gives Novo Nordisk an advantage over its competitor Eli Lilly in the race to bring an obesity pill to market. Lilly’s oral drug, orforglipron, is still under review.
Both pills belong to the GLP-1 class of drugs and work in the same way as widely used injectable medications: they mimic a natural hormone that regulates appetite and feelings of fullness, Euronews reports. In recent years, injectable Wegovy from Novo Nordisk and Zepbound from Lilly have dramatically transformed obesity treatment worldwide and in the United States, where 100 million people suffer from this chronic condition.
According to company representatives, Wegovy tablets will go on sale in the coming weeks.
Experts believe that the introduction of oral obesity medications could expand the rapidly growing market for such drugs by improving access and lowering costs.
About one in eight Americans has used injectable GLP-1 drugs, according to a survey by KFF, a nonprofit health research organization. However, many people struggle to afford the expensive injections.
“There is a whole segment of the population that could benefit from pills,” said Fatima Cody Stanford, an obesity specialist at Massachusetts General Hospital. “For me, it’s not just about who gets to the finish line first. What matters is that patients have options.”
Novo Nordisk’s obesity pill contains 25 milligrams of semaglutide—the same ingredient used in injectable Wegovy and Ozempic, as well as in Rybelsus, a lower-dose tablet approved for diabetes treatment in 2019.
In a clinical trial, participants taking oral Wegovy lost an average of 13.6% of their total body weight over about 15 months, compared with 2.2% among those taking a placebo. This is close to the results seen with injectable Wegovy, which produces an average weight loss of about 15%.
Chris Mertens, 35, a pediatric pulmonologist from Menomonee Falls, Wisconsin, joined a Novo Nordisk study in 2022 and lost about 40 pounds while taking Wegovy tablets. According to him, daily dosing reduced appetite and obsessive thoughts about food.
“There were times when I skipped a meal and barely noticed it,” Mertens said.
Participants in clinical trials who took the maximum dose of Lilly’s orforglipron lost an average of 11.2% of their total body weight over nearly 17 months, compared with 2.1% among those taking a placebo.
Both pills resulted in less weight loss than is typically achieved with Lilly’s Zepbound, or tirzepatide, which targets two gut hormones—GLP-1 and GIP—and produces an average weight loss of about 21%.
All GLP-1 drugs, both oral and injectable, have similar side effects, including nausea and diarrhea.
Both daily pills offer convenience, but Wegovy tablets must be taken in the morning on an empty stomach with a sip of water, followed by a 30-minute wait before eating or drinking.
This is because Novo Nordisk had to design the pill so that the drug would not be broken down in the stomach before being absorbed into the bloodstream. The manufacturer added a component that protects the medication in the gut for about 30 minutes and facilitates its action.
In contrast, Lilly’s orforglipron has no restrictions on how it is taken. This drug is being considered under a new FDA priority voucher program designed to shorten drug approval timelines. A decision is expected by spring.
Tablet production is generally cheaper than manufacturing injectable drugs, so the cost of the new oral medications may be lower. Earlier this year, the Trump administration said officials had been working with pharmaceutical companies to negotiate lower prices for GLP-1 drugs, which can cost more than $1,000 (about €848) per month.
The company reported that the starting dose will be available from some providers at a price of $149 (about €126) per month. Additional pricing information is expected in January.
It remains unclear what patients will prefer: daily pills or weekly injections.
According to obesity treatment experts, while some patients dislike injections, others are comfortable with weekly shots. Mertens switched to injectable Zepbound after he began regaining weight once the Wegovy tablet trial ended.
He said he liked the discipline imposed by a daily pill.
“It was a kind of mindful routine and a reminder: today I’m taking the medication, which means my decisions for the day will be different,” he said.
As noted by Angela Fitch, an obesity specialist and chief medical officer at knownwell, regardless of the format in which these drugs are delivered, the main advantage lies in making weight-loss medications more widely available and affordable.
“Price is everything,” she said. “Just give me a drug that costs $100 (about €84) a month and is reasonably effective.”
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