Semaglutide Injection (Wegovy) Approved in the US and Recommended in the EU for Adolescent Obesity Treatment
Novo Nordisk
Insulin Developer and Manufacturer
European Medicines Agency
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.
On March 30, the European Medicines Agency (EMA) website showed that the human medicines committee (CHMP) of the EMA recommended the approval of Novo Nordisk's semaglutide (Wegovy) for weight management in adolescents aged 12 years and above.
The opinion indicates that Wegovy can be used as an adjunct to a reduced-fat diet and increased exercise to help manage weight in adolescents aged 12 years and older with obesity or weighing more than 60kg. If the Body Mass Index (BMI) of adolescent patients does not decrease by 5% or more within 12 weeks after receiving treatment with 2.4mg or the maximum tolerated dose of Wegovy, the medication should be discontinued and the treatment plan reassessed.
Wegovy was approved for adult weight loss indications in the United States in June 2021. Since then, it has rapidly captured the weight loss drug market share due to its excellent weight loss effects, with sales reaching 6.188 billion Danish kroner (equivalent to 877 million US dollars) in 2022. On December 23, 2022, based on the positive results of the Phase III STEP TEENS study (see: ), Wegovy received FDA approval to expand its eligible population to adolescents aged 12 years and above. With the expansion of Wegovy's target population, its sales in 2023 are expected to grow further.
Wegovy Label Update Record (Source: FDA Official Website)
Wegovy Instructions (Source: FDA Official Website)
The phase III OASIS 1 study of oral semaglutide (Rybelsus) for weight loss will be completed in May this year, when Novo Nordisk will announce the results. This will determine whether semaglutide can become the first oral weight-loss product in the GLP-1 category.
Copyright © 2023 PHARMCUBE. All Rights Reserved.
Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article; if you need to reproduce it, please leave a message or send a message to the WeChat Official Account backend, and include the name and ID of the official account.
Disclaimer: The information in this WeChat article is for general reference only and should not be directly used as decision-making content. PharmaCube assumes no responsibility for any losses incurred by any party due to the use of the content herein.
PharmaCube Reader Survey Questionnaire
Thank you for your companionship. Looking forward to your feedback.
Scan the QR code to provide valuable suggestions