Empagliflozin CV Outcomes Data: Is Sum Of The Parts Greater Than Whole?
This article was originally published in The Pink Sheet Daily
Executive Summary
Boehringer and Lilly focus on CV death, are not seeking broader indication for Jardiance based on less impressive primary composite endpoint results.
You may also be interested in...
Jardiance's Cardiovascular Benefit Claim Bodes Well For Other Products Too
US labeling for Boehringer/Lilly's SGLT-2 inhibitor empagliflozin includes results from MACE primary endpoint and its individual components in the EMPA-REG trial, but indication statement is limited to CV risk reduction benefit.
Sanofi's Lixisenatide Gets Clean Bill Of Health On CV Safety, Heart Failure
ELIXA trial results show neither increased nor decreased risk of major adverse cardiovascular events; Sanofi's diabetes drug, still unapproved in the U.S., becomes the only GLP-1 receptor agonist with CV outcomes data.
Drug Shortages, Inspections In Focus At US FDA Appropriations Hearing
Commissioner Robert Califf discussed the agency’s request for $12.3m to address shortages and legislation to require that manufacturers provide more detailed information about increased demand and supply chain vulnerabilities.