Novo Nordisk’s attempt to gain an approval to treat heart failure patients with its obesity drug Wegovy has been put on hold.
In its quarterly earnings presentation, the Danish company said that after discussions with the FDA, it has pulled its filing and expects to resubmit in early 2025. The resubmission will include data from the company’s FLOW trial, which evaluates kidney outcomes with a once-weekly, 1-mg injection of semaglutide, Novo said.
It is a rare dose of misfortune for the company that has seen its value skyrocket with the success of its Type 2 diabetes treatment Ozempic and obesity follow-on Wegovy. In March of this year, Wegovy was approved to reduce the risk of cardiovascular events in adults with established heart disease who are obese or overweight.
A heart failure nod was expected to follow based on results of two trials—one in patients with heart failure and Type 2 diabetes and the other in non-diabetic patients with heart failure who are obese or overweight.
"When we did the meta analysis of the two trials, we see a 69% decrease in risk of CV death or hospitalization for heart failure, so absolutely very strong data," Martin Holst Lange, Novo's development chief, said on a Wednesday conference call.
But since the studies were "reasonably small," the FDA wanted to see an increase in the number of total cardio events to substantiate the effect of treatment with semaglutide, the Novo exec added.
In August of last year, Novo reported results from the phase 3 STEP HFpEF trial which showed that a weekly 2.4-mg dose of semaglutide—which matches the dose for Wegovy—topped placebo in reducing symptoms and physical limitations in patients with obesity and heart failure with preserved ejection fraction (HFpEF).
In the study, semaglutide administered over a year also helped patients lose an average of 13.3% of their body weight, versus a 2.6% average loss in the placebo group. HFpEF accounts for roughly 50% of patients with heart failure, and 80% of them are obese or overweight.
Separately, in the FLOW trial, chronic kidney disease patients who received a 1-mg dose of semaglutide saw a reduction in risk of major cardiovascular events by 18% and by all-cause mortality by 20%. Additionally, the rate of kidney function decline over time was “significantly slower” with semaglutide versus placebo, as tracked by estimated glomerular filtration rate—a common measure of kidney function.
Novo is competing in the space with Eli Lilly, which showed last week in a phase 3 trial that its GLP-1/GIP treatment tirzepatide reduced the risk of adverse heart failure outcomes by 38% compared to placebo. The company plans to submit tirzepatide's heart failure results to the FDA and other regulators "starting later this year," the company said at the time.
In addition to its benefits for patients with diabetes and obesity, tirzepatide has also shown its ability to combat sleep apnea and fatty liver disease.
While there has been reluctance by payers to provide coverage of drugs for weight loss, it is expected that coverage will become more widely available if the treatments are shown to provide benefits for those with heart and kidney problems.