AstraZeneca's Forxiga nabs expanded heart failure approval in Europe

AstraZeneca’s SGLT2 diabetes drug Forxiga has another approval to celebrate.

The drug, known as Farxiga in the U.S., gained a nod in Europe to treat patients suffering from heart failure with any type of left ventricular ejection fraction, including mildly reduced and preserved.

Ejection fraction is a measure of the amount of blood that leaves the left ventricle of the heart when it beats and spreads to the rest of the body. Previously, AZ's drug was only approved for heart failure with reduced ejection fraction.

The European approval comes as the FDA reviews AstraZeneca's heart failure expansion application in the U.S. AZ is seeking to expand Farxiga’s heart failure use in the U.S. include patients across the “full spectrum” of left ventricle ejection fraction, the company said in a recent statement.

If that application is approved, AZ's med would compete against Boehringer Ingelheim and Eli Lilly's rival SGLT2 inhibitor, Jardiance.

Meanwhile, in Europe, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) just last month recommended the drug's approval in this indication. The CHMP decision was based—in part—on an analysis showing Forxiga provided a morality benefit across the whole ejection fraction range.

Further, in the phase 3 DELIVER trial, AZ's med cut the occurance of cardiovascular death or worsening of heart failure by 18% compared with placebo in patients with mildly reduced ejection fraction and preserved ejection fraction. The effects of treatment remained consistent throughout the range of left ventricular ejection fraction, AZ said.

Heart failure affects about 15 million people in Europe, with approximately half dying within five years of diagnosis. It’s a chronic and long-term conditions that worsens with time and is the leading cause of hospitalization for those over 65 years old.

Other than heart failure, the diabetes drug scored approvals in chronic kidney disease in 2021. Farxiga was originally approved in 2014 as a Type 2 diabetes drug.