FDA fast-tracks BI, Lilly's Jardiance in chronic heart failure
When Boehringer Ingelheim and Eli Lillyís diabetes med Jardiance first showed CV benefits in trial patients, it changed the game for the SGLT2 inhibitor class. Now, not content to rest on its laurels, Jardiance is going after an indication in chronic heart failureóand the FDA just sped up the process.
The FDA Wednesday slapped its Fast Track designation on the drug as a treatment for reducing the risks of cardiovascular death and hospitalization for heart failure among chronic heart failure patients. The agency reserves the designation, which will help facilitate an expedited review and possible future approval, for novel therapies in areas of unmet clinical need, Boehringer said in a release.