Novo Nordisk's Wegovy Receives Positive CHMP Opinion for New Cardiovascular Indication in Europe

Source:Cailian Press

On Thursday (July 25) local time, Danish biopharmaceutical company Novo Nordisk announced on its official website that its重磅 weight-loss drug Wegovy has received support from EU regulators and is expected to add a new indication.

The press release stated that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a "positive opinion" on the label update for Wegovy.

Wegovy is the 2.4mg dose of subcutaneous semaglutide injection, marketed under the brand name Wegovy (Novo Ying) for the treatment of obesity, and Ozempic (Novo Tai) for the treatment of diabetes.

Novo Nordisk stated that this label update was based on cardiovascular data from patients in the "SELECT" trial. It is understood that SELECT is a randomized, double-blind, parallel-group, placebo-controlled Phase III trial.

The results showed that, compared with placebo, patients receiving Wegovy treatment had a 20% reduction in the primary endpoint—major adverse cardiovascular events (MACE), which was statistically significant and superior.

Moreover, the results of SELECT also showed that the reduction in MACE risk was achieved over a five-year period, regardless of baseline age, gender, race, ethnicity, body mass index (BMI), and the degree of renal impairment.

Novo Nordisk's Executive Vice President of Research and Development, Martin Holst Lange, wrote, "We believe that the EMA's recommendation for the Wegovy label update is an important milestone for patients with cardiovascular disease and obesity."

"SELECT data shows that, in addition to helping people manage their weight, Wegovy may also protect lives by reducing the risk of major adverse cardiovascular events."

Novo Nordisk expects that the EMA will implement the label update approximately one month after the CHMP issues a positive opinion. In March this year, the drug received approval from the U.S. Food and Drug Administration (FDA) for use as a cardiac treatment.

Editor: Ouyang Mingjun