Translated by AIVersione italiana
Key points
- The EMA’s approval
- What the experts say
- Oral formulations are also available in Europe
3′ min read
Translated by AIVersione italiana
An average weight loss of 17%, achieved by taking one tablet in the morning every day: 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 incretin-based formulations (GLP-1 and dual agonists)
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The EMA’s green light
The new medicine is indicated for adults with obesity, that is, with a body mass index of 30 kg/m² or above, and for adults who are overweight (that is, 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 who were obese or overweight and were followed for 64 weeks
Participants who took the oral medication, combined with a low-calorie diet and physical activity, lost an average of 17% of their body weight, compared with 2.7% in the placebo group
Even more interesting were 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
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, on a par with injectable therapies and superior to placebo and other upcoming oral treatments, both in terms of efficacy and a lower likelihood of treatment discontinuation due to side effects, as shown 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 incorporated into people’s daily routines. Semaglutide has also proven effective in reducing food cravings, 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 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 in late 2025 and orforglipron (the first non-peptide oral GLP-1 agonist) on 1 April 2026
At European level, as we have seen, 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 theinjectable therapies already available, and what the reimbursement timescales and procedures will be in individual European countries, including Italia
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