FDA Approves AstraZeneca’s Farxiga for Heart Failure

The FDA approved AstraZeneca’s Farxiga for reducing the risk of cardiovascular (CV) death and hospitalization in adults with heart failure.

The approval was based on the results of a phase 3 trial, which showed Farxiga significantly reduced CV death or hospitalization for heart failure compared to placebo. 

The agency granted the drug fast-track designation in September 2019 and a priority review earlier this year.