ROMA (ITALPRESS) – The European Commission has authorized the marketing of semaglutide in pill 25 mg of Novo Nordisk. This is the first oral treatment approved for weight management in Europe. It is indicated in adults with obesity (BMI equal to or greater than 30 kg/m2) and in adults with overweight (BMI equal to or greater than 27 kg/m2) with at least one comorbidity related to weight.
The approval follows the positive opinion of the EMA Committee for Medicinal Products and is based on the results of OASIS 4, which demonstrated the effectiveness of this new formulation, with a safety profile consistent with the treatment class with GLP-1 receptor agonists. Assumed once a day, the treatment showed an average weight loss of 17 percent in people with obesity or overweight (in the presence of one or more comorbidity), who took the pill, in combination with a hypocaloric diet and physical activity, compared to 2.7 percent observed with placebo. From the study it also emerges that one out of three responded early to therapy (early responder) obtaining even more significant results with an average weight loss of 22 percent at the end of the study (week 64).
The authorization also includes data from the SELECT study, which demonstrates the cardiovascular benefit of semaglutide, with a reduction of 20 percent of the risk of major adverse cardiovascular events (MACE) in patients with overweight or obesity.
“This treatment meets a concrete need: there are many people strongly motivated to deal with the management of their weight, but who so far have been waiting for a drug suitable for their specific needs and lifestyles,” explains Paolo Sbraccia, Professor of Internal Medicine of the Department of Systems Medicine at Tor Vergata Roma University. “For us clinical it means being able to treat excess weight and obesity effectively, also reducing the risk of related complications. This new formulation has shown significant results in weight loss in line with injective therapies and a superiority over placebo and other incoming oral treatments, both in terms of effectiveness, and less likely to terminate treatment due to side effects, as emerges from the indirect Orion analysis presented at the last European congress of obesity.”.
“Semaglutide in pill represents a step forward in weight management and control. Thanks to its features it can be easily integrated into the daily routine of people. It is important to underline,” comments Annamaria Colao, Ordinary of Endocrinology and Diseases of metabolism at the Federico II University of Naples “that this formulation has demonstrated a profile of use manageable even in the presence of concomitant treatments of wide use, including oral and statin contraceptives. Moreover, semaglutide has demonstrated its effectiveness also in the reduction of ‘food noise’6 that we know to be a real problem and with a strong impact on the quality of life of many people”.
“We are happy with the results achieved by this innovation that allows us to take a step forward to reach and support more and more people in their path of care,” says Jens Pii Olesen, General Manager Novo Nordisk Italia. “This approval is an important step towards those who are still today the dissatisfied needs of overweight or obesity and a concrete response to one of the public health challenges we face today.”.
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