Wegovy sNDA for Heart Failure Withdrawn

Novo Nordisk says it has withdrawn a supplemental NDA for its weight-loss drug Wegovy (semaglutide) that is seeking a heart failure indication. “Based on interactions with the FDA, Novo Nordisk has decided to withdraw the file and expects to resubmit the file in the beginning of 2025 with additional relevant data, including data from the once-weekly injectable semaglutide 1.0 mg kidney outcomes trial, FLOW,” the company says in an 8/7 earnings release.

The sNDA was filed in January and included data from the STEP HFpEF (Semaglutide Treatment Effect in People with Obesity and Heart Failure with Preserved Ejection Fraction) trials. Recent data published in The Lancet from the studies showed that “semaglutide was superior to placebo in improving heart failure-related symptoms and physical limitations, and reducing bodyweight in participants with obesity-related heart failure with preserved ejection fraction.”