Translated by AIVersione italiana
Key points
- The EMA’s go-ahead
- What the experts say
- Oral formulations are also available in Europe
3′ min read
Translated by AIVersione italiana
An average weight loss of 17 per cent, achieved by taking one tablet every morning: this is the data that convinced the European Commission to authorise the marketing of semaglutide 25 mg tablets (Novo Nordisk). For the first time in Europe, an oral treatment has been added to the therapeutic arsenal for weight management, alongside injectable formulations based on incretins (GLP-1 and dual agonists)
The EMA’s go-ahead
The new medicine is indicated for adults with obesity, i.e. with a body mass index of 30 kg/m² or above, and for overweight adults (i.e. with a BMI of 27 kg/m² or above), provided they have at least one weight-related comorbidity, such as high blood pressure, type 2 diabetes or dyslipidaemia. The approval follows a positive opinion from the EMA’s Committee for Medicinal Products for Human Use and is based on the results of the OASIS 4 study, which involved 307 adults with obesity or who were overweight, followed for 64 weeks. Participants who took the oral treatment, combined with a low-calorie diet and physical activity, lost an average of 17 per cent of their body weight, compared with 2.7 per cent in the placebo group. Even more interesting are the results for the so-called ‘early responders’: around one in three people responded immediately to the treatment, achieving an average weight loss of 22 per cent by the end of the study.
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What the experts say
“This treatment,” explains Professor Paolo Sbraccia, Professor of Internal Medicine at the University of Rome Tor Vergata and Director of the Internal Medicine Unit and the Obesity Medical Centre at the Tor Vergata Polyclinic, “meets a real need: there are many people who are highly motivated to manage their weight, but who have so far been waiting for a medicine suited to their specific needs and lifestyles. For us clinicians, this means being able to treat excess weight and obesity effectively, whilst also reducing the risk of related complications. This new formulation has demonstrated significant results in weight loss, in line with injectable therapies and showing superiority over placebo and other upcoming oral treatments, both in terms of efficacy and a lower likelihood of treatment discontinuation due to side effects, as revealed by the Orion indirect analysis, presented at the latest European Congress on Obesity.” “Semaglutide in tablet form,” comments Professor Annamaria Colao, Professor of Endocrinology and Metabolic Diseases at the Federico II University of Naples, “represents a step forward in weight management and control. Thanks to its characteristics, it can be easily integrated into people’s daily routines. Semaglutide has also demonstrated its effectiveness in reducing ‘food noise’, a real problem that has a significant impact on the quality of life of many people.”
Oral formulations are also available in Europe
The injectable formulation of semaglutide, administered weekly at doses of 2.4 mg and 7.2 mg, has already been approved by the FDA, the EMA and other regulatory authorities for weight loss and the maintenance of weight loss over time. The 25 mg tablet was developed as part of the OASIS Phase 3 clinical development programme, which enrolled a total of around 1,300 adults who were obese or overweight and had at least one comorbidity, testing doses of 25 mg and 50 mg per day. The FDA approved oral semaglutide at the end of 2025 and orforglipron (the first non-peptide oral GLP-1 agonist) on 1 April 2026. In Europe, as noted, the EMA granted approval for oral semaglutide on 16 July 2026, whilst the registration process for orforglipron is still ongoing. With semaglutide tablets, obesity treatment has thus officially entered the era of oral formulations, even in Europe. It remains to be seen how these new options will be integrated into everyday clinical practice, alongside the injectable treatments already available, and what the timing and reimbursement arrangements will be in individual European countries, including Italia.
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