FDA approves Eli Lilly’s once-daily obesity pill Foundayo

The US Food and Drug Administration approved Foundayo, a new once-daily pill for obesity treatment, on Wednesday. Eli Lilly, the manufacturer, also produces the weight-loss injection Zepbound. The approval positions Foundayo as the second obesity pill cleared by the FDA.

The FDA's approval came on Wednesday for Foundayo, developed by Eli Lilly as a once-daily oral medication targeting obesity. This decision allows the pill to enter the market amid growing demand for non-injectable weight-loss options. Eli Lilly, known for its injectable Zepbound, now expands its portfolio with this GLP-1-based pill, as first reported by WIRED. Foundayo joins a select group of obesity treatments, becoming only the second pill approved by the regulator for this purpose. Previously, Novo Nordisk received clearance for an oral version of its Wegovy injection. Industry observers note the competition will intensify between Eli Lilly and Novo Nordisk in the booming GLP-1 drug sector, though specific launch dates and pricing for Foundayo remain undisclosed.

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Illustration of oral semaglutide pill bottle with medical items symbolizing weight loss results from obesity trial.
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Oral semaglutide pill yields up to 16.6% weight loss in NEJM obesity trial

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A once-daily 25 mg oral form of semaglutide produced substantial weight loss in adults with obesity in a phase 3 study published in The New England Journal of Medicine, with a 16.6% mean reduction under an adherence-based analysis and 13.6% in the overall analysis. The results were accompanied by improvements in cardiometabolic risk factors and self-reported physical function. Novo Nordisk has submitted the therapy for U.S. approval and says U.S. manufacturing is underway; the FDA is slated to decide in the fourth quarter of 2025.

An investigation by India Today highlights how weak enforcement of regulations allows easy access to prescription-only weight-loss drugs in India, leading to increased misuse.

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Three Cochrane reviews commissioned by the World Health Organization evaluate GLP-1 receptor agonists like tirzepatide, semaglutide, and liraglutide for weight loss in people with obesity. The drugs show substantial weight reduction compared to placebo, but researchers note limitations in long-term data and industry funding influences. Side effects such as nausea are common, raising questions about broader access and safety.

Market data shows that users of GLP-1 weight loss drugs in the US are driving higher sales of premium chocolate, contrary to earlier expectations of declining demand. Households using these medications account for a larger share of chocolate purchases despite reduced overall appetite. This trend highlights a shift toward quality over quantity in indulgences.

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UK specialists say strict early access rules for the weight-loss drug tirzepatide (Mounjaro) risk creating a “two-tier” obesity treatment system, with people who can pay privately getting faster access than those relying on the National Health Service.

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Obesity has surged in South Africa, affecting nearly 11 million adults and costing R33 billion in 2020, equivalent to 16% of government health spending. Despite effective treatments like bariatric surgery and GLP-1 drugs such as Ozempic and Wegovy, medical schemes limit coverage, exacerbating the financial strain on patients and funders. New guidelines aim to reframe obesity as a chronic disease to improve access.

 

 

 

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