Europe Approves First Once-Daily Oral Medication for Weight Loss
The European Commission has officially authorized the marketing of a new 25 mg oral semaglutide pill, developed by Novo Nordisk, for the management of obesity and overweight. This authorization marks a significant milestone as it is the first oral treatment in the GLP-1 receptor agonist class approved in Europe for weight reduction.
The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). While the drug is now authorized for the European market, availability in Italy remains pending. Italian health authorities must still finalize negotiations regarding the drug’s pricing and determine whether it will be reimbursed by the national health service.
Clinical Efficacy and Study Results
The approval is primarily based on results from the OASIS 4 clinical study, which evaluated the efficacy of the 25 mg daily pill. Participants in the study who were treated with the medication, in combination with a low-calorie diet and increased physical activity, achieved an average body weight reduction of 17%. In comparison, the placebo group experienced an average weight loss of 2.7%.
The data further highlighted a subgroup of patients identified as “early responders.” Approximately one in three participants showed an early response to the therapy, achieving a more significant average weight loss of 22% by the end of the 64-week study. According to clinical evaluations, this 25 mg oral formulation demonstrates the highest efficacy for weight loss among oral options studied to date.
Target Population and Treatment Guidelines
The medication is specifically indicated for two categories of adults:
- Adults with obesity, defined as a Body Mass Index (BMI) of 30 kg/m² or higher.
- Adults who are overweight, defined as a BMI of 27 kg/m² or higher, provided they have at least one weight-related comorbidity, such as diabetes or cardiovascular disorders.
Medical experts emphasize that the drug must be taken once daily and integrated into a lifestyle plan that includes a calorie-restricted diet and physical exercise. Paolo Sbraccia, Professor of Internal Medicine at the University of Tor Vergata in Rome and Director of the Obesity Center at the Policlinico Tor Vergata, noted that the treatment addresses a concrete need for individuals who have been awaiting a medication suited to their specific life requirements and daily routines.
Integration into Clinical Practice
Regarding the transition from injectable therapies to the new oral pill, experts suggest that while the pill offers a new therapeutic pathway, the choice of treatment will ultimately remain at the discretion of the specialist, based on the specific needs of the patient.
Annamaria Colao, Professor of Endocrinology and Metabolic Diseases at the University Federico II of Naples, highlighted the practical advantages of the new formulation. She noted that the pill can be easily integrated into a person’s daily routine and has shown the ability to reduce “food noise,” a factor that often has a significant impact on the quality of life for many patients.
The company stated that the safety profile observed in clinical trials is consistent with the known profile for the GLP-1 receptor agonist class. Furthermore, the authorization incorporates data from the SELECT study, which evaluated the 2.4 mg injectable semaglutide. Those results indicated a 20% reduction in the risk of major adverse cardiovascular events (MACE)—defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke—in patients with overweight or obesity.
Find more reporting in our Health section.
Discover more from Archyworldys
Subscribe to get the latest posts sent to your email.
