U.S. regulators approve Wegovy pill for weight loss : NPR

U.S. regulators on Monday gave the green light to a tablet version of the popular weight-loss drug Wegovy, the first daily oral drug to treat obesity.

The U.S. Food and Drug Administration's approval has given drugmaker Novo Nordisk an edge over rival Eli Lilly in the race to sell obesity pills. Lilly's oral drug, orforglyprone, is still under review.

Both tablets are GLP-1 medications that act like commonly used injections to mimic the natural hormone that controls appetite and satiety.

In recent years, Novo Nordisk's Wegovy and Lilly's Zepbound injectables have revolutionized obesity treatment around the world and in the United States, where 100 million people suffer from the chronic disease.

Wegovy tablets are expected to be available within a few weeks, company officials said. The availability of oral obesity pills could expand the booming obesity treatment market by increasing access and reducing costs, experts say.

About one in eight Americans have used injectable GLP-1 drugs, according to a survey by KFF, a nonprofit health policy research group. However, many others have difficulty obtaining expensive vaccinations.

“These pills could benefit an entire population,” said Dr. Fatima Cody Stanford, an obesity expert at Massachusetts General Hospital. “For me, it’s not just about who crosses the finish line first. It’s about making sure these options are available to patients.”

The Novo Nordisk anti-obesity tablet contains 25 milligrams of semaglutide. It's the same ingredient in the injectable drugs Wegovy and Ozempic, as well as Rybelsus, a lower-dose pill approved for diabetes in 2019.

In a clinical study, participants taking Wegovy orally lost an average of 13.6% of their total body weight over about 15 months, compared to a 2.2% loss if they took a placebo or dummy pill. This is almost the same as the Wegovy injectable drug, with an average weight loss of about 15%.

Chris Mertens, 35, a pediatric pulmonologist from Menomonee Falls, Wis., joined the Novo Nordisk study in 2022 and lost about 40 pounds with the Vegovi pill. He said taking medication daily helped reduce his appetite and obsessive thoughts about food.

“If there were days when I skipped a meal, I hardly realized it,” Mertens said.

Clinical trial participants taking the highest dose of Lilly's orforgliprone lost an average of 11.2% of their total body weight over nearly 17 months, compared with a 2.1% loss for those taking 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, and resulted in an average weight loss of 21%.

All GLP-1 drugs, oral or injectable, have similar side effects, including nausea and diarrhea.

Both daily tablets promise convenience, but the Wegovy tablet must be taken with water in the morning on an empty stomach, with a 30-minute break before eating or drinking.

This is because Novo Nordisk had to design the tablet in such a way as to prevent the drug from being broken down in the stomach before it could be absorbed into the bloodstream. The drug's manufacturer has added an ingredient that protects the drug in the intestines for about 30 minutes and makes it easier to work.

In contrast, Lilly's orphorglipron has no dosage restrictions. The drug is being considered under the FDA's new priority voucher program, aimed at speeding up drug approval times. A decision is expected by spring.

Pills tend to be cheaper to produce than injected drugs, so the cost of new oral drugs may be lower. Earlier this year, the Trump administration said officials were working with drugmakers to negotiate lower prices for GLP-1 drugs, which can cost more than $1,000 a month.

The company said the starting dose will be available from some providers for $149 per month. Additional cost information will be available in January.

It is unclear whether patients would prefer daily pills or weekly injections. While some patients don't like needles, others don't seem to mind the weekly injections, obesity experts say. Mertens turned to the injectable drug Zepbound when he gained weight again after finishing a clinical trial of Wegovy tablets.

He said he liked the discipline of taking his pills every day.

“It was kind of an intentional routine and a reminder that I accept this today, to know that my choices will impact this day,” he said.

Dr. Angela Fitch, an obesity expert and chief medical officer of health care company knownwell, said that regardless of the format, the biggest benefit will be making weight-loss drugs more accessible and affordable.

“It’s all about price,” she said. “Just give me a relatively effective drug for $100 a month.”