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.

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