The U.S. Food and Drug Administration (FDA) has finally given the green light to the pill version of the popular weight-loss drug "Wegovy".
"The end of the injection era": Approval granted for the launch of the first oral drug for obesity.
This step represents the first approval in history for an oral drug specifically authorized to treat obesity.
This daily pill is expected to reach US markets by January 2025, offering a practical alternative to the injections that have revolutionized weight management in recent years.
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Danish pharmaceutical giant Novo Nordisk, the drug's manufacturer, confirmed that it is also working on launching the pill in the UK, with a marketing application to British regulators scheduled for 2026. This announcement followed extensive clinical trials that showed the daily pill, containing 25mg of the active ingredient semaglutide (also used in the injections "Wegovi" and the diabetes drug "Ozempic"), has the same efficacy as the injections.
The results of trials involving approximately 1,300 participants showed that after more than a year of taking the pill, the average weight loss was 16.6% of total body weight, while about a third of participants lost 20% or more. The CEO of Novo Nordisk described this development as offering patients "a convenient, once-daily pill" with the same effectiveness as the original injection.
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This announcement comes at a time when injectable GLP-1 drugs, such as Eli Lilly's Wegovi and Zippound, are experiencing a global surge in obesity treatment, particularly in the United States, where approximately 100 million people suffer from obesity. These drugs work by mimicking a natural hormone in the gut that suppresses appetite and increases feelings of fullness.
The oral formula is expected to expand the range of uses by overcoming obstacles such as the challenge of regular injections and supply shortages, and may also reduce costs in the long term, although its price has not yet been announced.
This move also gives Novo Nordisk an edge over its main competitor Eli Lilly, whose experimental daily pill Orfogliprone is still under regulatory review.
Simultaneously, another significant development is unfolding in Europe, with the European Medicines Agency (EMA) recommending the expansion of the use of potent weight-loss injections for children. The agency proposed allowing the prescription of Mongaro (also known as Terzepatide) for children aged 10 and older with type 2 diabetes, a move aimed at addressing the treatment gap for this age group, whose options were previously limited to metformin and insulin.
An advanced clinical trial published in The Lancet showed that children and adolescents who received the drug not only improved their blood sugar control, but also lost a significant amount of weight, averaging 11.2% of body mass over 30 weeks for the highest dose.
