The European Commission gives the green light, with an approval that arrived overnight and earlier than expected, to the first oral formulation of a GLP-1 receptor agonist for weight management. From the average loss of 17% to the cardiovascular benefits, here’s what changes for millions of people.
Overnight, the green light that the sector was waiting for arrived, but not so soon. With an authorization from European Commission arrived earlier than expected, semaglutide 25 mg in oral formulation of the Danish pharmaceutical company Novo Nordisk becomes the first GLP-1 receptor agonist in pill approved in Europe for weight management. A passage destined to mark a watershed in the therapy ofobesity and of overweightbecause for the first time one of the classes of drugs that has revolutionized the treatment of this chronic disease leaves the scope of injections and arrives in the form of a tablet to be taken once a day. The authorization concerns adults with obesity (body mass index equal to or greater than 30 kg/m²) and those with overweight (BMI of at least 27 kg/m²) in the presence of at least one weight-related pathology. The green light follows the favorable opinion expressed in recent weeks by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and confirms what emerged from the OASIS clinical program, which had already attracted the attention of the international scientific community. The European decision also comes as the debate on obesity continues to grow throughout Europe, where this pathology is now increasingly recognized as a chronic disease which requires structured and long-term therapeutic paths, as also recommended byWorld Health Organization and the main international scientific societies. After the green light from the European Commission the national path is now opening which will lead to the definition of the price and access methods by AIFA, an indispensable step before marketing in Italy: however, everything suggests that the pill may be available already in autumn.
Oral semaglutide: the first GLP-1 pill demonstrates efficacy close to injectable therapies
The aspect that makes this authorization particularly significant is not only the tablet format, but also the results obtained in clinical studies. In the trial OASIS 4in fact, patients treated with oral semaglutide together with a low-calorie diet and physical activity they obtained a average weight loss of 17%compared to 2.7% observed in the placebo group. Even more significant is the data relating to the so-called “early responders”: approximately one in three patients responded early to the treatment, reaching, at the end of the 64 weeks of the study, an average loss of 22% of body weight. Based on the clinical evidence available today, this is the oral formulation with the greatest demonstrated effectiveness in weight loss. A result that brings the performance of the tablet closer, at least indirectly, to that of the injectable formulations of semaglutide which in recent years have changed the therapeutic paradigm of obesity. The European authorization also includes the study data SELECTwhich had already changed the clinical perception of these drugs by showing how semaglutide is able to reduce by 20% risk of major cardiovascular events in patients with overweight or obesity and cardiovascular disease.
«This treatment responds to a concrete need: many people are strongly motivated to tackle their weight management, but until now they had been waiting for a therapy suited to their needs and lifestyle», observes Paolo Sbracciaprofessor of Internal Medicine at the University of Rome Tor Vergata and director of the Obesity Center of the Tor Vergata Polyclinic. According to the clinician, the availability of the oral formulation will allow obesity to be treated with an efficacy comparable to that observed with injectable formulations, also helping to reduce the risk of complications associated with excess weight. Sbraccia also underlines that, according to the indirect comparative analyzes presented at the last European Congress on Obesity of Istanbul, oral semaglutide shows superior results compared to other oral treatments in development, both in terms of efficacy and the lower probability of interrupting therapy due to side effects.
Also Annamaria Colaofull professor of Endocrinology at the Federico II University of Naples, highlights how the new formulation can be integrated more easily into patients’ daily lives. «It has demonstrated a manageable use profile even in the presence of very widespread drugs, such as statins and oral contraceptives, and has also shown benefits in reducing the so-called food noisethat continuous thought turned to food which profoundly affects the quality of life of many people.»
Because the pill could really change the treatment of obesity
The arrival of the first GLP-1 pill it could also profoundly change the organization of care. If injectable formulations have shown in recent years that they can change the natural history of the disease, the availability of a tablet could convince many people to start or continue a therapeutic path.
This is the belief of Luca Busettoassociate professor of Internal Medicine at the University of Padua and among the leading European experts on obesity. «The introduction of oral therapies represents a natural evolution in the treatment of obesity. It will make accessing treatments easierand we hope it will be accompanied by a strengthening of the care pathways of the National Health Service, so that obesity is managed stably like all other chronic diseases. The issues of reimbursement and costs remain openbut it is likely that oral formulations could contribute, over time, to making access to treatment more sustainable.”
According to Busetto, the new formulation could also represent an option for many patients already treated with injections. «It is reasonable to expect that some of the people on therapy today want to switch to the oral formulation, simply because prefers to avoid stings. We do not yet have randomized clinical trials dedicated to switching between injection and oral therapy, but the molecule is the same. Naturally, the tablet must be taken scrupulously following the instructions provided: in the morning, on an empty stomach and with an interval before breakfast, conditions necessary to guarantee correct absorption of the molecule.» The European approval comes at a time when obesity represents a major public health challenge. According to the WHO, the number of adults with obesity continues to increase throughout the European continent, while in Italy almost one in two adults is overweight. The availability of oral therapy it does not replace diet, physical activity and multidisciplinary managementbut expands the tools available to doctors.
«We are happy with the results obtained from this innovation», he concludes Jens Pii Olesengeneral manager of Novo Nordisk Italia. “This approval represents an important step in addressing the unmet needs of people with overweight and obesity and constitutes a concrete response to one of the major public health challenges of our time.” The approval that arrived overnight, with an unexpected acceleration compared to forecasts, therefore does not just represent a new regulatory green light. It marks the entrance to the first oral GLP-1 therapy for weight loss in European clinical practice and opens a new phase in the management of obesity. If GLP-1 agonists have changed the history of injection therapy, the availability of a tablet could now also help change the way millions of people approach treatment, breaking down one of the most common barriers: fear or refusal of the needle.
Obesity is one of the great health emergencies of our time
The arrival of the first semaglutide pill It is part of an increasingly worrying epidemiological context. According to theWorld Health Organization (WHO)in Europe almost six out of ten adults live with overweight or obesitya condition that contributes to the development of over two hundred pathologies, from type 2 diabetes to cardiovascular diseases, up to some tumors. Even in Italy the phenomenon continues to grow: data from the surveillance system of the Istituto Superiore di Sanità show that approximately 43% of adults is overweight, of which approx 33% are overweight and 10% have obesity. Numbers that increase with age and are higher in the most socially and economically disadvantaged groups. A burden that not only weighs on people’s health, but also on the sustainability of the National Health Service, making it increasingly urgent to expand the available therapeutic options and build structured and continuous treatment paths.
