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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.
“The submission of this new dose of Wegovy is another step forward in providing innovative solutions that meet the specific needs of people with obesity,” said Ludovic Helfgott, executive vice president and head of Product & Portfolio Strategy at Novo Nordisk. “This new dose was developed as a tailored option for people in need of additional support to achieve meaningful, sustained weight loss. With a reaffirmed safety and tolerability profile, we strongly believe in its potential to help even more people with obesity reach their individual weight loss as well as their broader health goals, including improvements in cardiovascular and kidney health, liver disease, type 2 diabetes and mobility through knee osteoarthritis pain reduction.”
"In addition to the submission to the EMA, Novo Nordisk aims to make the higher dose of Wegovy widely available throughout the EU," the company stated.
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751