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Novo’s Wegovy gets EMA nod to treat heart failure in obese people

Denmark’s Novo Nordisk got the backing of the European Medicines Agency for its Wegovy drug to reduce heart failure in obese people.
Photo Credit: Priscilla Du Preez 🇨🇦 on Unsplash

HQ Team

September 20, 2024: Denmark’s Novo Nordisk got the backing of the European Medicines Agency for its Wegovy drug to reduce heart failure in obese people.

When added to standard care semaglutide, branded as Wegovy, “can reduce heart failure-related symptoms and improve physical limitations and exercise function in people with obesity-related HFpEF, with or without type 2 diabetes,” according to a company statement.

Common causes of HFpEF, or heart failure and preserved ejection fraction, include hypertension, atrial fibrillation, age-related cardiac changes, and underlying structural heart abnormalities such as hypertensive heart disease. Other factors may include diabetes, obesity, and chronic kidney disease.

HFpEF, which accounts for about 50% of heart failure cases, is a condition in which heart muscles stiffen and draw in less blood.

‘Positive opinion’

The European Medicines Agency has “adopted a positive opinion” based on trials conducted in people with obesity-related HFpEF with or without diabetes. The drug is already used for weight-loss in obese people.

In both trials, Wegovy showed greater reductions in heart failure-related symptoms and greater improvements in physical limitations, as measured by the patient-reported Kansas City Cardiomyopathy Questionnaire Clinical Summary Score, alongside greater weight loss compared to placebo.

The beneficial effects were consistent regardless of baseline age, sex, race, ethnicity, body mass index, region, systolic blood pressure, left ventricular ejection fraction, and concomitant heart failure therapy, according to the Novo Nordisk statement.

“The recommendation to update the EMA label for Wegovy is an important step forward for people with obesity-related HFpEF who currently have limited treatment options,” said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk.

“Wegovy improves patients’ health-related quality of life, enabling them to live a life with greater functionality to conduct daily activities. These data further add to the body of evidence for the semaglutide molecule,” he said.

Heart failure and obesity

Heart failure affects at least 64 million people worldwide and is especially prevalent in those with obesity or type 2 diabetes.

Obesity is considered a key driver in the development and progression of HFpEF. Approximately 80% of people with HFpEF live with overweight or obesity, which is associated with symptoms including shortness of breath, swollen legs and feet and trouble exercising.

This can lead to poor quality of life due to the greater symptom burden and worse physical functioning. Despite therapeutic advances in HFpEF, significant unmet needs persist.

In the EU, apart from adults Wegovy is also indicated for paediatric patients aged 12 years and older.

The global weight management market size was valued at $142.58 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 9.94% from 2023 to 2030, according to Grand View Research. Asia Pacific was the dominant regional market and accounted for the largest revenue share of more than 37.68% in 2022.

Rising volumes of bariatric surgeries, rapid adoption of online weight loss & management programs, growth in disposable income levels in developing countries, increasing government initiatives for creating awareness about weight management, and growing cases of obesity due to sedentary lifestyles will fuel the growth.

According to the Institute of Health Metrics and Evaluation, 30.0% of the world’s population is either obese or overweight.

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