the U.S. Food and Drug management on Monday approved the first-ever GLP-1 pill for obesity from Wegovy maker Novo Nordisk, a landmark decision that health experts say could open up treatment access to more patients.
Novo Nordisk said it expects to launch the pill in early 2026. The danish drugmaker said starting in early January, the starting dose of 1.5 milligrams will be available in pharmacies and via select telehealth providers with savings offers for $149 per month.
That’s the same price that cash-paying patients can access the starting dose of the pill on President Donald Trump’s direct-to-consumer website, TrumpRx, under a deal Novo Nordisk struck with his administration last month. Trump’s site also launches in January.
Novo Nordisk did not say how much higher doses of the drug would cost, but said additional data on coverage and savings options for eligible patients will be available at that time as well.
Shares of Novo Nordisk gained roughly 10% in extended trading Monday.
The FDA’s approval also clears the pill for use to reduce the risk of major cardiovascular events, such as death, heart attack or stroke, in adults with obesity and established cardiovascular disease, according to Novo Nordisk.
That’s consistent with the approval label of the company’s blockbuster weight loss drug Wegovy, which shares the same active ingredient, semaglutide. Both work by mimicking the gut hormone GLP-1 to suppress appetite.
“What we’ve learned through years of research is that having an oral option really kind of opens up,activates and motivates different segments to seek treatment,” Dave Moore,novo Nordisk’s executive vice president of U.S. operations, told CNBC ahead of the approval. “To have that conversation with their doctor to see if this is something that might be right for them.”
“That’s what we’re excited about – to be able to give people an option and make sure we have access and ease of access like we have been doing with our injections,” he continued. He added that patients will have the “comfort and familiarity” on the safety and efficacy side since the pill contains the sa
Novo Nordisk’s Oral Wegovy Pill Approved: What to No About the New Weight Loss Option
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novo Nordisk has received FDA approval for an oral version of its popular weight loss drug, Wegovy (semaglutide), offering a convenient option to the injectable version. The approval is expected to intensify competition in the rapidly growing market for obesity treatments, with Eli Lilly’s oral weight loss pill, orforglipron, anticipated to be approved soon.
How Effective is the Wegovy Pill?
The approval is based on a Phase 3 clinical trial involving over 300 adults with obesity, but without diabetes. Results presented in 2024 showed that a 25-milligram daily dose of oral semaglutide led to an average weight loss of up to 16.6% over 64 weeks.When analyzing all patients, including those who discontinued the medication, the average weight loss was 13.6% [https://www.cnbc.com/2024/05/09/novo-nordisk-wegovy-pill-approved-by-fda-what-to-know.html].
This makes the pill slightly more effective than early data from Eli Lilly’s orforglipron,which is still awaiting FDA approval [https://www.cnbc.com/2024/05/09/novo-nordisk-wegovy-pill-approved-by-fda-what-to-know.html].
Key Differences from Eli Lilly’s Orforglipron
While both drugs aim to address obesity, they differ in their formulation and administration. Eli Lilly’s orforglipron is not a peptide medication, meaning it’s absorbed more readily by the body and doesn’t require the same dietary restrictions as Novo Nordisk’s pill.
Patients taking Novo Nordisk’s oral semaglutide must wait 30 minutes before eating or drinking anything after taking their dose. Though, Novo Nordisk argues this requirement isn’t a significant barrier to adherence, as many existing medications have similar guidelines. The company’s research suggests the routine can even reinforce medication adherence by prompting patients to take their pill with a glass of water in the morning [https://www.cnbc.com/2024/05/09/novo-nordisk-wegovy-pill-approved-by-fda-what-to-know.html].
addressing Concerns About Compounded Semaglutide
the approval of the oral Wegovy pill may also impact the market for compounded versions of semaglutide. During shortages of Ozempic and Wegovy over the past two years,compounded pharmacies legally produced versions of the drug,often at a lower cost,to meet demand. However, the FDA has since determined the semaglutide shortage is over, limiting the legal production of these compounded versions [https://www.fda.gov/drugs/drug-shortages/updates-semaglutide-shortages].
Novo Nordisk has expressed concern about the safety of illegally manufactured compounded versions, citing the use of unverified ingredients. “It continues to be alarming and disturbing for us,” said Novo Nordisk representative Doug Moore, referring to illegitimate ingredients used by some compounding pharmacies [https://www.cnbc.com/2024/05/09/novo-nordisk-wegovy-pill-approved-by-fda-what-to-know.html].
Manufacturing and Availability
Novo Nordisk states it is prepared to meet anticipated demand for the oral Wegovy pill, with manufacturing already underway at its facilities in North Carolina. The company also notes that the pill’s pricing will be closer to the cost of some previously available compounded versions, potentially increasing accessibility for patients [https://www.cnbc.com/2024/05/09/novo-nordisk-wegovy-pill-approved-by-fda-what-to-know.html].
Disclaimer: I am an AI chatbot and cannot provide medical advice. This information is for general knowledge and informational purposes only, and does not constitute medical advice. It is essential to consult with a qualified healthcare professional for any health concerns or before making any decisions related to your health or treatment.
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