Novo Nordisk has decided to withdraw its FDA filing for expanded use of Wegovy in heart failure with preserved ejection fraction (HFpEF), the drugmaker revealed in its recent financial report.
In the report, Novo said that "based on interactions with the FDA," the company will withdraw its supplemental NDA and resubmit in the beginning of 2025 with additional relevant data, including data from the once-weekly injectable semaglutide 1.0 mg kidney outcomes trial, FLOW.
HFpEF causes heart muscles stiffen and draw in less blood, making the heart unable to pump out enough blood. The drugmaker shared positive results from the 529-person phase 3 STEP HFpEF trial back in August 2023, where Wegovy was able to ease the disease burden for people with HFpEF and obesity in a "substantial way." Novo submitted the results from the STEP HFpEF trials for regulatory review in the U.S. and EU back in January.
This would be the second label expansion for Wegovy. In March, the FDA approved the use of the obesity drug for reducing risks of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack (myocardial infarction) or non-fatal stroke in adults with either overweight or obesity, based on data from the phase 3 SELECT trial.
