Novo Nordisk gains expanded approval for Wegovy to treat heart failure

Wegovy, the blockbuster weight loss drug from Danish drugmaker Novo Nordisk has now received expanded approval from the US FDA for use in the prevention of stroke and heart attacks. 

Wegovy is a semaglutide, as is Novo Nordisk’s other weight loss drug Ozempic, which belong to the GLP-1 agonist drug class. Both medications were developed for the treatment of Type 2 diabetes, working to reduce food cravings and slow the emptying of the stomach. 

Patients who suffer from obesity or are overweight are at "a higher risk of cardiovascular death, heart attack and stroke. Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health," commented John Sharretts, FDA's Director of the Division of Diabetes, Lipid Disorders, and Obesity. 

The weightloss drug from Novo Nordisk are already in use by millions of patients, now in several different countries, and Wegovy has also recently been approved for use in children aged 12–18 years. The new indication for the drug means that it will be accessible to many more patients. 

The rapid escalation in the prescription of the drug has led to some public concerns arising around the potential for abuse as a weight loss aid, this however is dismissed by experts saying that prescriptions are carried out by experienced practitioners. Efforts are also increasing to manage doses and monitor therapy, with Chad Weldy, a cardiologist at Stanford University, stating that he typically deferred to the primary care team to initiate and monitor therapy with drugs like Wegovy previously, but that he hopes to this change going into the future.

"Cardiology groups will need to fully incorporate these therapies into clinic and build a clinical workflow to manage dose escalation, side effects, and insurance approval," Weldy asserted.

The US FDA have noted that patients administered with Wegovy should be monitored for kidney disease, diabetic retinopathy and depression or suicidal behaviours or thoughts by a medical professional. 

Novo Nordisk conducted a 33 month-long clinical trial – SELECT – involving 17,605 patients, where the drug was shown to decrease the risk of non-fatal heart attack by 28%, non-fatal stroke by 7%, and heart-related death by 15% in patients with pre-existing heart conditions, when compared with a placebo. The cardioprotective effects were seen very early on in the study, suggesting that these results were not solely due to subsequent weightloss. 

The expanded approval for Wegovy could encourage higher purchasing of the drug despite its high cost (currently at US$1,349 for a month’s supply of doses). 

Obesity experts in the US have also highlighted the potential of Eli Lilly’s weightloss drug, Zepbound, as a treatment for heart conditions, with the therapy undergoing tests in late-stage trials for treatment of heart failure later on in 2024. 

Source: 

Reuters. FDA approves Novo Nordisk's Wegovy for lowering heart risks. [Date accessed 11/03/2024] www.reuters.com/business/healthcare-pharmaceuticals/fda-approves-novo-nordisks-wegovy-use-reducing-heart-attack-risks-2024-03-08/