Biotech
Friday, August 25th, 2023 9:06 am EDT
Two weeks ago, Danish drugmaker Novo Nordisk released results of a large trial showing its weight loss drug Wegovy can help prevent heart attacks and strokes in overweight people with cardiovascular disease. It followed up on those landmark data Friday with further evidence the injectable drug helps protect the heart.
In people with a form of heart failure, Wegovy reduced disease symptoms and improved quality of life and exercise duration by more than placebo, according to results from the trial, codenamed “STEP-HFpEF.” The data were released at the European Society of Cardiology meeting and published in The New England Journal of Medicine.
The newly released data could further help Novo persuade insurers to provide broader coverage for Wegovy, which carries a list price of more than $17,000 a year. Insurers might be more open to offering coverage if they know the shot can avert expensive hospitalizations and episodes of care.
Broad coverage also could help Novo retain its lead over rival Eli Lilly, which has a similarly acting drug Mounjaro that is approved to treat diabetes but not yet weight loss.
In heart failure, the heart can’t pump as much blood as it should. The disease can be caused by a variety of conditions, including a previous heart attack, high blood pressure or obesity. Participants in STEP-HFpEF were therefore different from those in Novo’s prior heart study, who qualified because they’d had heart attacks, strokes or other cardiovascular complications caused by blocked blood vessels.
STEP-HFpEF enrolled 516 people with “preserved ejection fraction,” meaning their hearts can still pump at least 45% of what a healthy heart can. Half were randomized to take Wegovy while the other half got a placebo. They took their assigned injection for 52 weeks.
On the primary heart failure measure, a 100-point symptom scale based on a questionnaire, people who received Wegovy reported higher scores by an average of 17 points, significantly more than the nine-point improvement among people taking the placebo.
A secondary measure tested how far patients can walk in six minutes. At the end of the trial, people taking Wegovy could walk 22 meters further, much greater than the one-meter improvement seen with people on placebo.
Trial researchers also measured weight loss. Patients taking Wegovy lost an average of 13% of their body weight, versus the only 3% loss in the placebo arm.
“The encouraging findings for semaglutide in patients with heart failure with preserved ejection fraction reported here potentially add a much-needed extra option for these patients and provide another upstream treatment for patients with signs of this condition plus a high [body-mass index],” wrote Yigal Pinto, a cardiology professor at the University of Amsterdam, in an accompanying editorial in NEJM. Semaglutide is Wegovy’s scientific name.
However, Pinto wrote that “hard endpoints” like hospitalizations and cardiovascular death will be necessary to judge how well drugs like Wegovy perform in treating heart failure when compared to another class of diabetes drugs headlined by Lilly and Boehringer Ingelheim’s Jardiance.
Novo measured such events in the trial, but there weren’t enough to show a statistically significant difference. They are also being measured in a confirmatory trial, called STEP-HFpEF DM, which Novo will need to complete before submitting the data to the Food and Drug Administration and other regulators. That trial is due to wrap up in October.
This post has been syndicated from a third-party source. View the original article here.
