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OCTOBER 21, 2019

Farxiga Granted New Indication for CV Reduction in Diabetic HF Patients

By PPN News Staff

The FDA granted a new indication for dapliglozin (Farxiga, AstraZeneca) to reduce the risk for hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.

The approval is based on results from the DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 CV outcomes trial (CVOT), the largest sodium-glucose cotransporter 2 inhibitor CVOT conducted to date to evaluate diabetic