Wegovy (semaglutide once weekly) application is withdrawn from the FDA for heart failure
In its quarterly earnings presentation, Novo Nordisk said that after discussions with the FDA, it has withdrawn its Wegovy filing and expects to resubmit in early 2025.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
In March 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 approval 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 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.
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