FDA Extends Farxiga Approval to Reduce Risk of Hospitalization, Death From Heart Failure

The FDA has extended its approval of AstraZeneca’s drug Farxiga for additional indications to reduce the risk of cardiovascular death and hospitalization for heart failure and urgent heart failure.

The drug has previously been approved in the US for adults with heart failure with reduced ejection fraction — a lower amount of blood pumped out of the left ventricle.

Heart failure impacts almost seven million people in the U.S. and “approximately half of heart failure patients die within five years of diagnosis,” the company says.

Farxiga’s Phase III trials showed a reduced risk of death from any cardiovascular cause, and reduced total hospitalization for heart failure issues, with no evidence that the effects differed by level of ejection fraction.

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