With Thursday’s positive opinion from the Committee for Medicinal Products for Human Use, the matter now heads to the European Commission which will have the final say on whether Wegovy’s label will be updated.
The European Medicines Agency on Thursday recommended an update to the label of Novo Nordisk’s weight-loss treatment Wegovy (semaglutide) to reflect its cardiovascular benefits.
The label update would include data from the STEP HFpEF and STEP HFpEF-DM studies, which showed that Wegovy could significantly reduce heart failure-related symptoms in patients with obesity-related heart failure with preserved ejection fraction (HFpEF), regardless of type 2 diabetes status. The trials also demonstrated that Wegovy can improve physical limitations and exercise function in these patients.
Martin Holst Lange, head of development at Novo Nordisk, in a statement called the support for the label update “an important step forward” for patients suffering from obesity-related HFpEF, who currently have very limited treatment options. “Wegovy improves patients health-related quality of life, enabling them to live a life with greater functionality to conduct daily activities,” Lange said.
Thursday’s positive opinion from the Committee for Medicinal Products for Human Use (CHMP) will help guide the European Commission (EC) in delivering its final verdict on the matter. Novo is confident that the review will come out in the company’s favor, noting in its announcement that the company “expects implementation of the EU label update shortly.”
In July 2024, Novo also won the support of CHMP to update Wegovy’s label with data from SELECT. The late-stage study showed that Novo’s GLP-1 therapy, when given on top of standard care, could cut the risk of major adverse cardiovascular events (MACE) by 20% in adults with established cardiovascular disease. MACE include cardiovascular death, non-fatal heart attack or non-fatal stroke.
At the time, Lange called the update “a significant milestone” for patients, highlighting that Wegovy “has the potential to protect lives” by cutting MACE risk.
Semaglutide, sold by Novo as Wegovy in obesity, won FDA approval to reduce the risk of cardiovascular death, heart attack and stroke in adults who have cardiovascular disease and are obese or overweight in March 2024.
In support of the cardiovascular benefits of Wegovy, and of GLP-1 receptor agonists more broadly, research firm Dandelion Health published a report earlier this week. Using real-world clinical data and an AI-enabled analytic algorithm, Dandelion concluded that GLP-1 treatments could be used as “primary prevention” intervention against MACE in “clinically silent patients,” or those who are otherwise symptom-free.
Dandelion’s analysis showed that GLP-1s could cut the risk of MACE by 15% to 25%, which, according to the firm, can be extrapolated to the primary prevention setting, where approximately 44 million patients could benefit from early GLP-1 intervention. In this case, GLP-1 treatments could potentially prevent up to 17,300 heart attacks and 16,700 strokes in the U.S. annually.
