French agency places Novo Nordisk’s anti-obesity drug under close surveillance

Danish laboratory Novo Nordisk has announced the launch of its anti-obesity drug Wegovy in France, but the country's drug safety agency has already said it will monitor its use to ensure it is not misused for aesthetic purposes.

Wegovy is one of the GLP-1 analogues (aGLP-1), a new type of treatment that has become very popular in the fight against obesity as it helps patients lose weight quickly.

Due to the injection of an active substance, semaglutide, the same as that used in Novo Nordisk's other anti-diabetic drug Ozempic, patients feel full.

If used in higher doses and in cases where the patient is obese, the substance can lead to vomiting, nausea or diarrhoea.

For the French market, Novo Nordisk announced that Wegovy will be available on prescription. Expected to cost between €9 and €12, it will not be covered by the national health insurance system, the Danish laboratory added.

It is hoped that Wegovy will "enable many French patients to follow a treatment pathway that includes a low-calorie diet and increased physical activity, which is still essential," the managing director of Novo Nordisk's French subsidiary, Etienne Tichit said in a message sent to AFP.

ANSM cautious

But similar drugs have been misused for aesthetic purposes by people who do not need the treatment from a medical perspective.

While the French agency has given its approval for the drug's marketing in France, it is placing the drug under close surveillance to avoid its use by people who are not overweight or obese and who do not have weight-related health problems.

"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 agency's press release reads.

Only a doctor specialising in endocrinology-diabetology-nutrition or with "applied nutrition" training can prescribe Wegovy, the ANSM wrote, adding that general practitioners may only renew patients' prescriptions afterwards.

The ANSM is also asking doctors treating obesity to prescribe aGLP-1 to patients with an initial body mass index (BMI) greater than or equal to 35 kg/m2 under the age of 65.

"These recommendations will be reassessed as the situation evolves," ANSM added.

Wegovy was given the green light by the European Medicines Agency (EMA) in early 2022 for the management of obesity in adults and in early 2023 for adolescents aged over 12.

In Europe, Wegovy is already marketed in Germany, Spain, Switzerland and the UK.

[Edited by Daniel Eck]