Novo Nordisk Withdraws FDA Submission for Wegovy’s Heart Failure Indication, Plans to Reapply Next Year

Withdrawal of Submission:
Novo Nordisk has withdrawn its FDA submission for the use of Wegovy in heart failure with preserved ejection fraction (HFpEF).

Reason for Withdrawal:
The company is waiting for more comprehensive data on cardiovascular outcomes, including hospitalizations and cardiovascular-related deaths, to strengthen its application.

Reapplication Plans:
Novo Nordisk intends to resubmit its application early next year once additional data is available.

Competitor Comparison:
This decision follows Eli Lilly's recent topline results for its obesity drug Zepbound, which showed a 38% reduction in major cardiovascular problems in HFpEF patients.

Initial Submission:
The initial submissions to regulators in the U.S. and Europe were made in January.