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.”

  • But Lilly’s tirzepatide already has shown an impressive benefit on heart failure outcomes in patients with obesity that appears better than other drugs approved for HFpEF, including SGLT-2 inhibitors

Incretins, and Wegovy in particular with its obesity and cardiovascular outcomes claims, have been seen as products whose sales are only limited by manufacturing capacity. But Novo posted lower than expected income this quarter, and it seems competition and reimbursement considerations can limit the flight paths of even the most soaring products

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