Novo Nordisk Seeks Approval For Higher Wegovy Dose In Europe

Danish pharmaceutical company Novo Nordisk (NVO) on Tuesday said that it has submitted an application to the European Medicines Agency (EMA) for the approval of a new and higher dose of its blockbuster obesity treatment, Wegovy.

NYSE-listed shares of the company were trading over 1% higher at the time of writing.

The submission to the EMA is based on data from two trials investigating the efficacy and safety of a higher dose of Semaglutide, the active ingredient in Wegovy, in people with obesity with or without type 2 diabetes. While one of the trials included 1,407 adults with obesity and not diabetes, the other included 512 adults with obesity and type 2 diabetes.

The new 7.2 mg dose of Wegovy 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, the company said.

Data also indicated that Semaglutide 7.2 mg had a well-tolerated safety profile consistent with Semaglutide 2.4 mg, Novo Nordisk added.

Ludovic Helfgott, executive vice president and head of Product & Portfolio Strategy at Novo Nordisk, said that the new dose was developed as a tailored option for people in need of additional support to achieve meaningful, sustained weight loss.

In addition to the submission to the EMA, Novo Nordisk aims to make the higher dose of Wegovy widely available throughout the European Union.

Wegovy is among Novo Nordisk’s blockbuster drugs. In the first quarter, Wegovy sales stood at DKK 17,360 million ($2.72 billion), marking a growth of 85% from the corresponding period of 2024, and accounting for over 22% of the company’s total sales in the period.

On Stocktwits, retail sentiment around Novo Nordisk stayed unmoved within the ‘bearish’ territory over the past 24 hours while message volume stayed at ‘extremely low’ levels.

NVO stock is down by over 18% this year and by about 51% over the past 12 months.

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