US regulators approve Wegovy pill, first oral medication to treat obesity | US healthcare
U.S. regulators on Monday gave the green light to a pill version of the blockbuster weight-loss drug Wegovy, the first daily oral medication to treat obesity.
The US Food and Drug Administration’s approval gives drugmaker Novo Nordisk an edge over rival Eli Lilly in the race to market an obesity pill. Lilly’s oral medication, or forglipron, is still being studied.
Both pills are GLP-1 drugs that work like commonly used injectables to mimic a natural hormone that controls appetite and feelings of fullness.
In recent years, Novo Nordisk’s injectable Wegovy and Lilly’s Zepbound have revolutionized the treatment of obesity globally and in the United States, where 100 million people have the chronic disease.
Wegovy pills are expected to be available within a few weeks, company officials said. The availability of oral pills to treat obesity could expand the burgeoning market for obesity treatments by expanding access and reducing costs, experts said.
About one in eight Americans use injectable GLP-1 drugs, according to a survey from KFF, a nonprofit health policy research group. But many more are struggling to afford expensive vaccines.
Massachusetts General Hospital obesity specialist Dr. “There’s a whole demographic that could benefit from the pills,” Fatima Cody Stanford said. “For me, it’s not just about who crosses the finish line first. It’s about making these options available to patients.”
Novo Nordisk obesity pill contains 25 mg semaglutide. This is the same ingredient in the injectable drugs Wegovy and Ozempic and Rybelsus, a lower-dose pill approved in 2019 to treat diabetes.
In one clinical study, participants taking Wegovy by mouth lost an average of 13.6% of their total body weight over about 15 months, compared with 2.2% if they took a placebo or dummy pill. This is almost the same as the injectable Wegovy, with an average weight loss of around 15%.
Chris Mertens, 35, a pediatric lung doctor in Menomonee Falls, Wisconsin, participated in the Novo Nordisk trial in 2022 and lost nearly 40 pounds using the Wegovy pill. He said the daily medication worked to reduce his appetite and intrusive thoughts about food.
“If there were days I missed a meal, I barely noticed,” Mertens said.
In a clinical trial, participants taking the highest dose of Lilly orforgliprone lost an average of 11.2% of their total body weight over approximately 17 months, compared with 2.1% in those taking a placebo.
Both pills resulted in less weight loss than the average achieved with Lilly’s Zepbound or tirzepatide, which targets two gut hormones, GLP-1 and GIP, leading to an average weight loss of 21%.
All GLP-1 medications taken orally or injected have similar side effects, such as nausea and diarrhea.
Both daily pills promise convenience, but the Wegovy pill should be taken in the morning on an empty stomach with a sip of water, taking a 30-minute break before eating or drinking.
That’s because Novo Nordisk had to design the pill to prevent the drug from breaking down in the stomach before being absorbed into the bloodstream. The drug manufacturer added an ingredient that preserves the drug in the intestine for about 30 minutes, making it easier for it to work.
In contrast, Lilly’s orforgliprone has no dose restrictions. This drug is being considered under the FDA’s new priority voucher program, which aims to shorten drug approval times. A decision is expected in the spring.
It is generally cheaper to produce pills than to make drugs by injection, so new oral drugs may cost less. The Trump administration said earlier this year that officials were working with drugmakers to negotiate lower prices for GLP-1 drugs, which could cost more than $1,000 a month.
The company said a starting dose is available from some providers for $149 a month. Additional information on cost will be available in January.
