Post WHO alert, Novo Nordisk seeks EMA nod for higher dose of obesity treatment Wegovy
Denmark: Following a recent World Health Organization (WHO) alert on semaglutide-containing medicines, Novo Nordisk has announced the submission of an application to the European Medicines Agency (EMA) for approval of a new, higher dose of its obesity treatment, Wegovy (subcutaneous semaglutide 7.2 mg).
Read also: Post WHO alert, Novo Nordisk seeks EMA nod for higher dose of obesity treatment Wegovy
The submission to the EMA is based on clinical data from the STEP UP and STEP UP T2D trials, investigating the efficacy and safety of semaglutide 7.2 mg in adults with obesity in STEP UP, and adults with obesity and type 2 diabetes in STEP UP T2D. In the STEP UP trial, the new dose of Wegovy (semaglutide 7.2 mg) demonstrated a substantial average weight loss of 21% in people with obesity, with a third of participants losing 25% or more of their body weight compared with placebo. Data also indicated that semaglutide 7.2 mg had a well-tolerated safety profile consistent with semaglutide 2.4 mg and the previous, robust, Novo Nordisk semaglutide trials.
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