Novo Nordisk pulls its FDA heart failure submission for Wegovy, will reapply early next year

cafead

Administrator
Staff member
  • cafead   Aug 07, 2024 at 12:03: PM
via Novo Nordisk’s attempt to gain an approval to treat heart failure patients with its obesity drug Wegovy has been put on hold.

In its quarterly earnings presentation, the Danish company said that after discussions with the FDA, it has pulled its filing and expects to resubmit in early 2025. The resubmission will include data from the company’s FLOW trial, which evaluates kidney outcomes with a once-weekly, 1-mg injection of semaglutide, Novo said.

article source