France to Closely Monitor Novo Nordisk's Wegovy for Misuse
Key Insights
Novo Nordisk is launching its anti-obesity (search) drug Wegovy in France, but the drug safety agency will closely monitor its use.
Wegovy contains semaglutide, which helps patients feel full, but can lead to vomiting, nausea, or diarrhea if misused.
The French agency emphasizes that Wegovy should only be used as a second-line treatment, combined with diet and exercise.
Novo Nordisk's anti-obesity (search) drug, Wegovy, is set to launch in France, but the Agence Nationale de Sécurité du Médicament (ANSM), the country's drug safety agency, has announced it will closely monitor the drug's use to prevent misuse for aesthetic purposes. Wegovy, a GLP-1 analogue, has gained popularity for its ability to facilitate rapid weight loss.
The drug utilizes semaglutide, the same active substance found in Novo Nordisk's anti-diabetic drug Ozempic, to create a feeling of fullness in patients. However, higher doses, particularly in non-obese individuals, can lead to adverse effects such as vomiting, nausea, and diarrhea. In France, Wegovy will be available via prescription, with an estimated cost between €9 and €12, and will not be covered by the national health insurance system.
ANSM's Cautious Approach
While the ANSM has approved Wegovy for marketing in France, it is implementing strict surveillance measures to ensure the drug is not used by individuals who are not overweight or obese and do not have weight-related health issues. The agency emphasizes that Wegovy should be reserved as a second-line treatment, only to be used when diet management has failed, and in combination with a low-calorie diet and physical activity.
"This drug should only be used as a second-line treatment, in the event of failure of diet management and in combination with a low-calorie diet and physical activity," the ANSM stated in a press release.
Prescription Guidelines
The ANSM has stipulated that only doctors specializing in endocrinology-diabetology-nutrition or with "applied nutrition" training can initially prescribe Wegovy. General practitioners are permitted to renew prescriptions after the initial prescription from a specialist. The agency also recommends that doctors prescribing GLP-1 analogues limit their use to patients with an initial body mass index (BMI) of 35 kg/m2 or greater and who are under 65 years of age.
"These recommendations will be reassessed as the situation evolves," the ANSM added, indicating a flexible approach based on ongoing monitoring and data.
Wegovy received approval from the European Medicines Agency (EMA) in early 2022 for obesity (search) management in adults and in early 2023 for adolescents over 12. It is currently marketed in several European countries, including Germany, Spain, Switzerland, and the UK.