Novo Readies For Victoza CV Benefit Claim With US FDA Panel Nod
Executive Summary
HeartofType2 unbranded campaign is aimed at increasing awareness of CV disease in type 2 diabetics. FDA advisory committee strongly endorses new claim for the GLP-1 agonist but recommends limiting it to diabetics with established CV or chronic kidney disease.
You may also be interested in...
Novo Nordisk Says More To Victoza Outcomes Benefit Than A GLP-1 Class Effect
Novo Nordisk's ESC satellite symposium on heels of FDA approval of CV event prevention claim for Victoza highlights differences compared to Sanofi's competing Lyxumia, which failed an outcomes study.
Disappointing Bydureon EXSCEL Outcomes Data May Raise Stakes For Victoza
AstraZeneca's EXSCEL study could have created confidence in a GLP-1 class-wide outcomes benefit, but instead it has raised questions about whether differences in trial results boil down to trial design.
BI/Lilly's Jardiance Is First Diabetes Drug With CV Benefit Claim
Companies are supporting new US-labeled indication for cardiovascular mortality risk reduction with a consumer education campaign, direct-to-consumer advertising and cardiologist detailing.