FDA Approves First Daily Pill for Obesity Treatment, Wegovy Set to Expand Access
The U.S. Food and Drug Administration’s approval of a daily pill version of Wegovy marks a significant step forward in obesity treatment, promising to broaden access and potentially lower costs for millions.
U.S. regulators on Monday authorized the oral formulation of Wegovy, a blockbuster weight-loss drug, making it the first daily oral medication specifically approved to treat obesity. This decision gives drugmaker Novo Nordisk a competitive edge over rival Eli Lilly, whose oral obesity drug, orforglipron, remains under FDA review.
Both Wegovy and orforglipron belong to a class of drugs known as GLP-1s, which mimic a natural hormone that regulates appetite and promotes feelings of fullness. These medications have already revolutionized obesity treatment in recent years, with Novo Nordisk’s injectable Wegovy and Lilly’s Zepbound leading the charge, particularly in the U.S., where an estimated 100 million people live with chronic obesity.
According to company officials, the Wegovy pills are anticipated to become available within weeks. Experts predict that the availability of oral options will expand the burgeoning market for obesity treatments by making them more accessible and affordable. Currently, approximately 1 in 8 Americans have used injectable GLP-1 drugs, according to a recent survey by KFF, a nonprofit health policy research group, but many more are priced out of the market due to the high cost of injections.
“There’s an entire demographic that can benefit from the pills,” stated 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 oral Wegovy pill contains 25 milligrams of semaglutide, the same active ingredient found in the injectable versions of Wegovy and Ozempic, as well as Rybelsus, a lower-dose pill approved for the treatment of diabetes in 2019.
Clinical trial data revealed that participants taking oral Wegovy experienced an average weight loss of 13.6% of their total body weight over approximately 15 months, compared to a 2.2% loss in the placebo group. This outcome is comparable to the weight loss achieved with injectable Wegovy, which averages around 15%.
Chris Mertens, a 35-year-old pediatric lung doctor from Menomonee Falls, Wisconsin, participated in the Novo Nordisk trial in 2022 and lost approximately 40 pounds while using the Wegovy pill. He described the medication as effectively reducing his appetite and diminishing intrusive thoughts about food. “If there were days where I missed a meal, I almost didn’t realize it,” Mertens shared.
In a separate clinical trial, participants receiving the highest dose of Lilly’s orforglipron lost an average of 11.2% of their total body weight over nearly 17 months, compared to a 2.1% loss in the placebo group. However, both pills resulted in less weight loss than Lilly’s Zepbound (tirzepatide), which targets two gut hormones – GLP-1 and GIP – and demonstrated an average weight loss of 21%.
Like all GLP-1 drugs, both oral pills are associated with similar side effects, including nausea and diarrhea.
While both medications offer the convenience of a daily pill, the Wegovy pill requires specific administration: it must be taken with a sip of water on an empty stomach in the morning, with a 30-minute waiting period before consuming food or other beverages. This unique requirement stems from Novo Nordisk’s design to prevent the drug from being broken down in the stomach before it can be absorbed into the bloodstream. The company incorporated an ingredient to protect the medication for about 30 minutes within the gut, enhancing its effectiveness.
Lilly’s orforglipron, in contrast, has no such dosing restrictions. The drug is currently being reviewed under the FDA’s priority voucher program, which aims to expedite drug approval times, with a decision anticipated by spring.
Generally, producing pills is less expensive than manufacturing injectable drugs, suggesting that the new oral medications could be more affordable. The Trump administration previously announced efforts to negotiate lower prices for GLP-1 drugs, which can currently cost upwards of $1,000 per month. Novo Nordisk has announced a starting price of $149 per month for the initial dose, with further cost information expected in January.
The preference for daily pills versus weekly injections remains uncertain. While some patients are averse to needles, others find the routine of weekly injections manageable. Mertens, after completing the Wegovy pill trial, transitioned to injectable Zepbound when he experienced weight regain. He appreciated the structured discipline the daily pill provided. “It was a little bit of an intentional routine and a reminder of today I’m taking this so that I know my choices are going to be affected for the day,” he explained.
Dr. Angela Fitch, an obesity expert and chief medical officer of knownwell, a healthcare company, emphasized that regardless of the format, the most significant benefit will be increased accessibility and affordability of weight-loss medications. “It’s all about the price,” she stated. “Just give me a drug at $100 a month that is relatively effective.”
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