CV Risk Assessment For All Obesity Drugs Seems Inevitable Pre-Approval Requirement
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee March 29 voted 17-6 that all obesity drugs should be vetted for cardiovascular risk, but some could rely on a meta-analysis rather than an outcomes trial.
You may also be interested in...
Orexigen Sheds LIGHT On Potential CV Benefit For Contrave
The biotech disclosed in an SEC filing that its obesity drug may actually provide a cardiovascular benefit to patients based on early results from an ongoing outcomes study.
Eric Colman, FDA’s Lead Obesity Drug Reviewer, Dies At Age 53
As a reviewer, team leader and deputy director in the Division of Metabolism and Endocrinology Products, Colman spearheaded the agency’s policy development on weight-management products.
At Liraglutide Panel Review, A Call For CV Studies To Look Beyond MACE
If cardiovascular studies are required for non-cardiac drugs, they should be focused on specific signals of heart-related concern that may not include ischemic events, advisory committee cardiologists say during review of Novo Nordisk’s Saxenda for obesity.