Novo Will Go After MACE Indication For Victoza Based On LEADER
This article was originally published in The Pink Sheet Daily
Executive Summary
Positive cardiovascular outcomes data for Victoza were outlined at ADA, and Novo Nordisk said it plans to file an sNDA with FDA seeking a broad indication to include reduction in major adverse cardiac events (MACE). The indication is different than the one Lilly is pursuing for Jardiance.
You may also be interested in...
Victoza’s Non-Cardio Safety May Dominate At FDA Panel Review
US FDA does not raise any major concerns about study’s design or results to support cardiovascular risk reduction claim for Novo Nordisk’s GLP-1 agonist liraglutide ahead of advisory committee, but agency gives close scrutiny to non-CV safety events of interest.
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.
Keeping Track: New Submissions In Bladder Cancer, HCV And Diabetes; Avastin Label Expands
The latest drug development news and highlights from our FDA Performance Tracker.