Novo Nordisk notched another win Friday as its mega blockbuster Wegovy (semaglutide) proved to also help patients with a common type of heart failure. The Danish pharma company announced results from a Phase III trial, published in The New England Journal of Medicine, adding to the drug’s growing list of benefits.
The STEP trial compared Wegovy’s highest dose with a placebo in patients with heart failure with preserved ejection fraction (HFpEF) as well as obesity. The condition comprises around half of all heart failure cases and affects daily life with symptoms of fatigue, shortness of breath, reduced ability to exercise and swelling of extremities.
In addition to losing 13.3% of their body weight, patients saw a significant improvement on KCCQ-CSS, a cardiomyopathy questionnaire that includes both physical function and quality of life. A 2.4 mg weekly dose of Wegovy resulted in a 16.6-point increase in KCCQ-CSS, versus 8.7 points with placebo. In addition, treated patients’ six-minute walking distance was greater than placebo by 20 meters.
HFpEF has long been listed as a comorbidity to obesity. However, studies like this support the idea that the heart condition could be a primary driver of the disease.
“It’s not just a coexisting condition, it’s a root cause of the development and progression of heart failure in a large number of these patients, and should absolutely be the target for intervention,” Mikhail Kosiborod, lead investigator of the trial and vice president of research at Saint Luke’s Health System, told STAT News.
Analysts are predicting annual sales for Wegovy and its diabetes label Ozempic of between $4 billion and $5 billion for 2023. Novo's shares have climbed 19% this year as sales have skyrocketed to the point of causing a struggle for the company to keep up with demand.
Novo said in its second-quarter earnings call that lower-strength starter doses in the U.S. would continue to be restricted as manufacturing capacity expands to ensure supply for patients already on the drug is not interrupted. The Danish drugmaker is leveraging Thermo Fisher Scientific as Wegovy demand surges and amid production problems with manufacturer Catalent, Reuters reported on Wednesday.
Friday’s STEP data release is the second trial to show that Wegovy can improve heart health. Earlier this month, the company posted Phase III results from the SELECT trial, demonstrating that Wegovy injections significantly reduced the occurrence of major adverse cardiovascular events by 20% as compared with placebo.
Another study is examining Wegovy’s effect in HFpEF patients with both obesity and diabetes. After completing it later this year, Novo anticipates filing for a label update in the first half of 2024.
A trial for an oral formulation of semaglutide has also demonstrated significant weight loss for obese patients with a 17.4% decrease in body weight at 68 weeks.
Competition is heating up as approval for Eli Lilly’s GLP-1 drug, already on the market for diabetes, nears anticipated approval for obesity as well. Boehringer Ingelheim and Pfizer are also working to join the lucrative market with an injectable and oral GLP-1 drugs, respectively.
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