FDA approval for Farxiga in new indication in heart failure patients

Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type-2 diabetes (T2D), says Anglo-Swedish pharma major AstraZeneca (LSE: AZN), whose shares were up more than 3% at 8,780 pence by mid-afternoon today.

The approval by the Food and Drug Administration was based on positive results from the landmark Phase III DAPA-HF trial, which showed Farxiga achieving a statistically-significant and clinically meaningful reduction of CV death or hospitalisation for heart failure (HF), compared to placebo.

This application received Priority Review designation, meaning the agency planned to take action on the application within six months, noted the FDA