Novo Nordisk has withdrawn its application to expand the label of Wegovy, its blockbuster weight loss medication, the company announced Aug. 7.
In 2021, the Denmark-based drugmaker began a trial to test the safety and efficacy of Wegovy use among adults who are obese and are diagnosed with heart failure with preserved ejection fraction.
Novo Nordisk published promising results from the trial, finding large reduction in symptoms and physical limitations, and the drugmaker submitted the data for regulatory review in the U.S. and E.U.
But, "based on interactions with the FDA, Novo Nordisk has decided to withdraw the file," according to the drugmaker's financial report for the first half of 2024. Novo Nordisk said it plans to resubmit the file in early 2025 with more data, including results from its kidney outcomes trial.
As of Aug. 7, Wegovy is approved for chronic weight management and to reduce the risk of cardiovascular death, heart attack and stroke in adults who have cardiovascular disease and are either obese or overweight.