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U.S. regulators have approved the first-ever oral version of the popular weight-loss drug Wegovy, marking a significant milestone in obesity treatment. The Food and Drug Administration’s decision on Monday gives pharmaceutical company Novo Nordisk an important edge over competitor Eli Lilly in the rapidly expanding market for obesity medications.
The pill contains semaglutide, the same active ingredient found in injectable Wegovy and diabetes treatment Ozempic. Like these medications, the oral version works by mimicking GLP-1, a naturally occurring hormone that regulates appetite and feelings of fullness.
“There’s an entire demographic that can benefit from the pills,” said Dr. Fatima Cody Stanford, an obesity specialist 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.”
Novo Nordisk officials indicated the medication should be available to patients within weeks. The company stated that the starting dose would cost $149 per month through select providers, with additional pricing information expected in January.
Clinical trials demonstrated impressive results for the oral formulation. Participants lost an average of 13.6% of their body weight over approximately 15 months, compared to just 2.2% among those taking a placebo. These results approach the effectiveness of injectable Wegovy, which typically achieves about 15% weight loss.
Dr. Chris Mertens, a 35-year-old pediatric lung specialist from Wisconsin who participated in the clinical trial, lost about 40 pounds using the pill. “If there were days where I missed a meal, I almost didn’t realize it,” Mertens said, noting how the medication decreased his appetite and reduced invasive thoughts about food.
The approval comes at a critical moment, as obesity affects approximately 100 million Americans. According to a survey from health policy research group KFF, about one in eight Americans has used injectable GLP-1 drugs, but many more struggle with affordability issues related to these expensive treatments.
The development of oral alternatives could significantly expand treatment access. Manufacturing pills is generally more economical than producing injectable medications, potentially leading to lower costs. The Trump administration recently announced negotiations with pharmaceutical companies to reduce prices for GLP-1 medications, which can currently cost upwards of $1,000 monthly.
While oral Wegovy offers convenience, it comes with specific administration requirements. The pill must be taken each morning on an empty stomach with a sip of water, followed by a 30-minute wait before eating or drinking. This protocol is necessary because Novo Nordisk incorporated an ingredient that protects the medication from stomach acid degradation, allowing it to be absorbed properly.
Eli Lilly’s competing oral drug, orforglipron, is still under FDA review through a priority voucher program designed to accelerate approval times. A decision is expected by spring. In clinical trials, orforglipron showed slightly less weight loss than Wegovy’s pill, with participants losing an average of 11.2% of their body weight over nearly 17 months. However, orforglipron offers a potential advantage with no dosing restrictions.
Both medications demonstrated less weight loss than Eli Lilly’s injectable Zepbound (tirzepatide), which targets two gut hormones—GLP-1 and GIP—and has achieved an impressive 21% average weight reduction. All GLP-1 medications, whether oral or injectable, share similar side effects, primarily gastrointestinal issues like nausea and diarrhea.
Dr. Angela Fitch, an obesity expert and chief medical officer at healthcare company knownwell, emphasized that accessibility and affordability remain paramount. “It’s all about the price,” she said. “Just give me a drug at $100 a month that is relatively effective.”
The approval represents another significant step in the rapidly evolving field of obesity treatment, where pharmaceutical options are increasingly challenging traditional approaches focused on diet and exercise alone. As these medications become more accessible, they could fundamentally change how obesity is managed for millions of Americans struggling with the chronic condition.
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16 Comments
This is an interesting development in the battle against obesity. Having an oral version of Wegovy could provide more options for patients who may be hesitant about injections. The pricing will be a key factor in determining its accessibility.
You’re right, the pricing will be crucial. Hopefully Novo Nordisk keeps it affordable so more people can benefit from this new treatment.
It will be interesting to see how the oral Wegovy pill compares to the injectable version in terms of efficacy and side effects. Expanding the treatment options for obesity is important, but the new pill needs to prove itself in the market.
Good point. The clinical trial results will be closely scrutinized, and real-world data will be crucial in determining if the oral pill can match the performance of the injectable Wegovy.
While the availability of an oral version of Wegovy is positive, I’m curious to see how it will be positioned in the market compared to the injectable form. Cost, convenience, and patient preference will all play a role in determining its success.
The approval of an oral version of Wegovy is a positive step forward in the fight against obesity. Providing more options for patients is always a good thing, as different treatments may work better for different individuals.
I agree. The more tools we have in the toolbox, the better. Oral medication could be a game-changer for some patients who struggle with injections.
This is an interesting development, but I’m curious to see how the oral Wegovy pill will be positioned relative to the injectable version. Will it offer similar weight loss benefits, or will there be tradeoffs in terms of efficacy or side effects?
The expansion of treatment options for obesity is a positive development, but the long-term sustainability and safety of these medications will need to be closely monitored. Maintaining a balanced and healthy lifestyle should always be the primary focus.
Well said. While these new drugs can provide valuable support, they should not be seen as a substitute for addressing the root causes of obesity through lifestyle changes and comprehensive medical care.
The approval of an oral weight-loss medication is a promising step, but the key will be ensuring equitable access for all patients who could benefit. Cost and insurance coverage will be critical factors to monitor going forward.
You raise a good point. Affordability and insurance coverage will be vital to making this new treatment option truly accessible, especially for underserved populations.
The approval of an oral weight-loss medication is a significant milestone, but the high cost of these treatments remains a concern. Ensuring affordable access to effective obesity therapies should be a priority for regulators and pharmaceutical companies.
I agree, the pricing will be a major factor in determining the accessibility of this new treatment option. Affordable access is crucial for addressing the growing obesity epidemic.
The approval of an oral version of Wegovy is an exciting advancement, but the real test will be how it performs in the real world. Patients and healthcare providers will need to carefully weigh the benefits and risks of this new treatment option.
Absolutely. The long-term safety and efficacy data will be crucial in determining the role of this oral medication in the overall obesity treatment landscape.