Novo Pulls Wegovy Heart Failure Application, Will Resubmit To Get ‘Hard Endpoints’ In Label

However, Lilly already has outcomes data for tirzepatide, meaning Novo could lose the race to market with a heart failure claim even after being first to the US FDA.

The FDA had some disappointing news for Novo Nordisk. • Source: Shutterstock

Novo Nordisk A/S’s decision to pull its heart failure applications for Wegovy (semaglutide) illustrates that blockbuster drugs can still face challenges with labeling subtleties.

Key Takeaways

Novo expects to resubmit semaglutide for a heart failure claim early next year, calling the delay in the hopes of a better label “a really good bargain.”

Incretins, and Wegovy in particular with its obesity and cardiovascular outcomes claims, have been seen as products whose sales are...