CHMP says yes to BI/Lilly's empagliflozin after FDA snub
This article was originally published in Scrip
Executive Summary
The EU's CHMP has given the go-ahead to for approval for Boehringer Ingelheim and Lily's SGLT2 inhibitor empagliflozin (Jardiance), just weeks after the US FDA refused to approve the product until BI had resolved deficiencies at the manufacturing facility where the product will be produced.