Novo Nordisk announced on May 22 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending the approval of the Wegovy 7.2 mg single-dose injection pen for marketing in the European Union for weight management in adult patients with obesity.

The 7.2 mg dose is the highest approved maintenance dose for Wegovy to date. Previously, EU physicians could prescribe the 7.2 mg dose but it required administration as three separate 2.4 mg injections. The newly recommended single-dose pen combines these three injections into one, significantly improving convenience for patients.

The CHMP's positive opinion is based on data from the STEP UP Phase III clinical trial program. Studies showed that in obese adults without type 2 diabetes, once-weekly injections of Wegovy 7.2 mg achieved an average weight reduction of 20.7%, with approximately one-third of patients achieving weight loss of 25% or more. In obese patients with type 2 diabetes, the average weight reduction was 14.1%. Regarding safety, the adverse reaction profile for the 7.2 mg dose was consistent with that of the previously approved lower-dose versions.

Mike Doustdar, President and CEO of Novo Nordisk, stated that since its launch in 2021, Wegovy has transformed the lives of many people living with obesity, and the 7.2 mg high dose can deliver approximately 21% weight loss. With the recommendation for the single-dose pen, patients with obesity can look forward to achieving their weight and health goals through a more convenient and user-friendly injection device.

Novo Nordisk anticipates a formal launch of the Wegovy 7.2 mg single-dose pen in the European Union in the third quarter of 2026. The product is already marketed in the United States under the brand name Wegovy HD. Boosted by this news, Novo Nordisk's stock price rose approximately 2.4% on the day.