CHMP recommends approval of extension to marketing terms for Wegovy in weight management.- Novo Nordisk
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Wegovy (semaglutide once weekly injection) from Novo Nordisk for obesity.
The CHMP adopted an extension to the existing indication as follows:in addition to adults, Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with obesity and body weight above 60 kg. Treatment with Wegovy should be discontinued and re-evaluated if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose.
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