Novo Nordisk’s weight-loss drug has been recommended by the European Medicines Agency’s human medicines committee for use in adolescents aged 12 years and older with obesity and a minimum weight of 60kg.
The positive opinion from the Committee for Medicinal Products for Human Use (CHMP) follows the recent approval of semaglutide, also known as Wegovy, in the EU for adults who are either obese or overweight with at least one weight-related health condition.
The US label for semaglutide has already been extended to include adolescents, following the US Food and Drug Administration originally approving the drug for adults in 2021.
Semaglutide, which is also available under the brand names Ozempic and Rybelsus, suppresses patients’ appetites by mimicking an intestinal hormone called GLP-1, which is released after eating. By making people feel fuller, it should help to reduce overall calorie intake.
The CHMP’s decision follows positive results from the phase 3 STEP TEENS clinical trial that included 201 adolescents aged 12 to 17. Of those patients in the semaglutide treatment group, 73% lost at least 5% of their starting body weight by the end of the study.
In its recommendation, the committee specified that treatment with semaglutide should be ‘discontinued and re-evaluated’ if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4mg or maximum tolerated dose.
Childhood overweight rates, including pre-obesity and obesity, have been growing worldwide over the past decades.
According to the Organisation for Economic Co-operation and Development (OECD), more than 18% of adolescents aged 15 years were overweight or obese on average across its 27 member countries in 2018.
Semaglutide was first developed for diabetes, before its benefits in aiding weight loss led Novo to develop it specifically for obesity.
Diabetes has continued to be a key focus for the company, which recently announced a research and development partnership with Dewpoint Therapeutics aimed at identifying drug candidates to treat insulin resistance and diabetic complications.
The collaboration will see the partners use Dewpoint’s discovery and AI technology platform to identify modulators of biomolecular condensates – membraneless organelles comprising proteins and RNA – that may be involved in insulin resistance and insulin sensitivity.