European Regulator Backs Approval Of Novo Nordisk High-Dose Wegovy

On Friday, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Novo Nordisk A/S’ (NYSE:NVO) higher dose of Wegovy (semaglutide 7.2 mg).

Novo Nordisk has also applied to the EMA for a single-dose device to deliver Wegovy 7.2 mg.

Additionally, semaglutide 7.2 mg is currently under review in the U.S., U.K., and several other countries.

Also Read: FDA Weighs Rapid Review For Eli Lilly Obesity Pill As Novo Nordisk Nears Launch

What Data Shows?

In the U.S., Novo Nordisk received the Commissioner’s National Priority Voucher (CNPV) and submitted semaglutide 7.2 mg to the FDA in November 2025.

The new dose of Wegovy has demonstrated an average weight loss of 20.7% at 72 weeks in people with obesity who do not have diabetes.

These substantial weight loss results complement the already established health benefits of Wegovy in obesity-related complications, including a significant reduction in the risk of cardiovascular events such as heart attack and stroke, and a reduction in pain from knee osteoarthritis.

The positive opinion is based on the results from the STEP UP and STEP UP T2D clinical program.

In people with obesity and without diabetes, one in three participants treated with Wegovy achieved 25% or more weight loss at 72 weeks, with a safety and tolerability profile consistent with the approved Wegovy 2.4 mg semaglutide dose.

Data showed that the majority (84%) of the weight lost with Wegovy came from fat mass loss, with tests confirming that muscle function was preserved.

NVO Price Action: Novo Nordisk shares were up 0.05% at $50.31 at the time of publication on Friday, according to Benzinga Pro data.

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