In a landmark decision for weight-loss medicine, United States regulators have approved the first daily oral medication specifically designed to treat obesity. The US Food and Drug Administration (FDA) gave the green light on Monday to a pill version of the blockbuster drug Wegovy, handing its manufacturer, Novo Nordisk, a significant advantage in the competitive market for obesity treatments.
A New Front in the Weight-Loss Drug Race
This approval positions Novo Nordisk ahead of its main rival, Eli Lilly, in the race to bring an oral obesity medication to patients. Lilly's own pill, orforglipron, remains under regulatory review. Both oral treatments belong to the class of GLP-1 drugs, which mimic a natural gut hormone to suppress appetite and increase feelings of fullness, similar to the wildly popular injectables like Wegovy and Lilly's Zepbound.
These injectable drugs have revolutionised the approach to obesity, a chronic condition affecting an estimated 100 million people in the US alone. However, their high cost and injectable format have been barriers for many. A recent survey by the health policy group KFF found that while one in eight Americans has used a GLP-1 injectable, affordability remains a critical issue.
"There’s an entire demographic that can benefit from the pills," said Dr Fatima Cody Stanford, an obesity expert at Massachusetts General Hospital. "For me, it’s not just about who gets it across the finish line first. It’s about having these options available to patients."
How Effective is the Wegovy Pill?
The newly approved pill contains 25mg of semaglutide, the same active ingredient found in injectable Wegovy and Ozempic, as well as in Rybelsus, a lower-dose pill already approved for type 2 diabetes.
In a key clinical trial, participants taking the oral Wegovy lost an average of 13.6% of their total body weight over approximately 15 months. This compares to an average loss of just 2.2% for those on a placebo. The result is nearly on par with the injectable form of Wegovy, which leads to about 15% average weight loss.
Chris Mertens, a 35-year-old paediatric lung doctor from Wisconsin who participated in the trial, reported losing around 40 pounds. He described how the daily pill reduced his appetite and intrusive thoughts about food. "If there were days where I missed a meal, I almost didn’t realize it," Mertens said.
For context, participants in a trial for Lilly's oral orforglipron lost an average of 11.2% of body weight over 17 months. Both pills show slightly less efficacy than Lilly's injectable Zepbound (tirzepatide), which targets two hormones and achieved an average 21% weight loss.
Convenience with a Caveat and the Cost Question
While offering the convenience of a daily pill, the Wegovy oral medication comes with specific instructions. It must be taken with a sip of water first thing in the morning on an empty stomach, followed by a 30-minute wait before eating or drinking anything else. This is due to a special ingredient that protects the drug from stomach acids for about half an hour, allowing it to be absorbed. Lilly's contender, orforglipron, has no such dosing restrictions.
A major potential benefit of the pill format is cost. Manufacturing pills is generally cheaper than producing injectable drugs, which could translate to lower prices for patients and health systems. The current injectable GLP-1 drugs can cost over $1,000 per month. Novo Nordisk has indicated the starting dose of the oral medication will be available for $149 per month through some providers, with more detailed pricing expected in January.
Novo Nordisk stated the Wegovy pills should be available within weeks. Their arrival is anticipated to significantly broaden the booming market for obesity treatments by offering a more accessible and potentially less expensive option for the millions living with the condition.
