Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
Biosimilars Deals 2023
Biosimilars Deals 2024
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Trade Marks

NEW INDICATION ALERT: FDA Approves Novo Nordisk’s Wegovy® (semaglutide) for Cardiovascular Risk Reduction

Mar 8, 2024

Novo Nordisk announced that the FDA approved a label expansion for Wegovy® for reducing risks of major adverse cardiovascular events (MACE) including death, myocardial infarction, or stroke in adults with obesity and/or established cardiovascular disease (CVD).  The approval is based on results of the SELECT trial, which demonstrated that Wegovy® reduced MACE by 20%.  It is the first US approved therapy to assist with weight management and reduce cardiovascular risk. 

Novo Nordisk has also requested equivalent label expansion in EU with the decision expected in 2024. 

The approval comes soon after Novo Nordisk announced results of its FLOW study for Ozempic®  (semaglutide) for kidney outcomes.

This news follows the announcement on 5 February 2024 by Novo Holdings (Novo Nordisk’s parent company) that it will acquire global contract development and manufacturing company Catalent for USD $16.5B.