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.