In a landmark decision for weight management medicine, United States regulators have approved the first daily oral medication specifically designed to treat obesity.
A New Front in the Weight-Loss Drug Race
The US Food and Drug Administration (FDA) granted approval on Monday for a pill version of the blockbuster drug Wegovy. This move hands its manufacturer, Danish pharmaceutical giant Novo Nordisk, a significant advantage in the competitive race to bring an oral obesity treatment to market, placing it ahead of rival Eli Lilly.
Lilly's own oral candidate, orforglipron, remains under regulatory review. Both pills belong to the GLP-1 class of drugs, which work by mimicking a natural gut hormone that regulates appetite and promotes feelings of fullness, similar to the mechanism of widely used injectables like Wegovy and Lilly's Zepbound.
These injectable treatments have revolutionised obesity care globally in recent years, offering new hope in countries like the US, where approximately 100 million adults live with the chronic disease.
Expanding Access and Improving Convenience
Company officials stated the Wegovy pills are expected to be available within weeks. Experts believe the arrival of an oral option could dramatically expand the booming market for obesity treatments by broadening access and potentially reducing costs.
A survey from the health policy research group KFF found about one in eight Americans has used an injectable GLP-1 drug. However, the high price tag, often exceeding $1,000 per month, places them out of reach for many.
"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."
The new Novo Nordisk pill contains a 25mg dose of semaglutide, the same active ingredient found in injectable Wegovy, diabetes drug Ozempic, and the lower-dose diabetes pill Rybelsus, which was approved in 2019.
Clinical Results and Patient Experience
In a key clinical trial, participants taking 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 taking 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 using the daily pill. He described how the medication reduced his appetite and intrusive thoughts about food. "If there were days where I missed a meal, I almost didn't realise it," Mertens said.
In its trial, the highest dose of Lilly's orforglipron led to an average weight loss of 11.2% over nearly 17 months, versus 2.1% for a placebo. Both oral treatments resulted in less weight reduction on average than Lilly's injectable Zepbound (tirzepatide), which targets two hormones and achieved about 21% average weight loss.
All GLP-1 medications, whether oral or injectable, share similar potential side effects, including nausea and diarrhoea.
Practical Differences and Future Outlook
While both daily pills offer convenience, they have different usage requirements. The Wegovy pill must be taken with a sip of water first thing in the morning on an empty stomach. Patients must then wait 30 minutes before eating or drinking anything else.
This specific instruction is due to the pill's design, which includes a protective ingredient to prevent the drug from breaking down in the stomach before it enters the bloodstream. In contrast, Lilly's orforglipron candidate has no such dosing restrictions.
Lilly's drug is being reviewed under an FDA priority voucher programme aimed at shortening approval times, with a decision anticipated by spring.
Producing pills is generally less expensive than manufacturing injectable drugs, which could lead to lower costs for patients. The Trump administration noted earlier this year that officials had engaged with drugmakers to negotiate lower prices for GLP-1 medications.
Novo Nordisk indicated the starting dose of the oral Wegovy would be priced at $149 per month through some providers, with more detailed cost information expected in January.
