EMA to take a closer look at Wegovy's cardiovascular data this week

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) may consider a potential new indication based on the cardiovascular data.
Photo: Staff
Photo: Staff
af marketwire

This week, the European health authorities’ Committee for Medicinal Products for Human Use (CHMP) will review Novo Nordisk’s cardiovascular data with the weight loss drug Wegovy, Reuters reports with reference to the agenda for the monthly meeting of the CHMP from January 22 to 25.

At the meeting, a decision may be made on a possible new indication based on the cardiovascular data, Reuters writes.

During the fall, Novo Nordisk submitted a supplemental filing for Wegovy in order to obtain approval that the drug reduces the risk of serious cardiac events such as death, blood clots and stroke in obese people with a BMI above 27 and established cardiovascular disease.

The registration application is based on the Select cardiovascular study, which last year showed that Wegovy reduces the risk of serious cardiovascular events defined as cardiovascular death, blood clots and stroke by 20% compared to placebo.

Novo Nordisk submitted a similar application in the US in October last year and announced in November that the US application will be fast-tracked.

The US Food and Drug Administration has given the application ”priority review”, which cuts months off the authorities’ processing time.

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