Novo Nordisk Seeks EMA Approval for Higher-Dose Wegovy® After Impressive Trial Results

Novo Nordisk has submitted a new application to the European Medicines Agency (EMA) seeking approval for a higher dose (7.2 mg) of its obesity drug Wegovy® (semaglutide). This move is part of the company’s broader mission to expand treatment options and deliver tailored solutions for individuals living with obesity.

The EMA submission is supported by clinical data from the STEP UP and STEP UP T2D trials. In the STEP UP study, adults with obesity receiving the 7.2 mg dose of semaglutide achieved an average weight loss of 21%, with about one-third of participants losing 25% or more of their body weight. The safety profile of the higher dose was consistent with the lower-dose formulations previously tested and approved.

“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. 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,” said Ludovic Helfgott, executive vice president and head of Product & Portfolio Strategy at Novo Nordisk. 

Novo Nordisk will also seek to widely avail the 7.2 mg dose of Wegovy 23 across the European Union, strengthening its efforts in enhancing obesity treatment and outcomes with evidence-based, patient-centred therapies.