With FDA nod, AstraZeneca's Farxiga gains ground in heart failure race with Jardiance

AstraZeneca’s heart, kidney and diabetes drug Farxiga lagged its Eli Lilly and Boehringer Ingelheim counterpart last year after Jardiance bagged an approval to treat a wider spectrum of heart failure (HF) patients. But a fresh green light for AstraZeneca’s med could put the SGLT2 rivals neck and neck once again.

AZ’s Farxiga, sold as Forxiga in certain markets and known as dapagliflozin, won an FDA nod to cut the risk of cardiovascular (CV) death, heart failure hospitalization and urgent HF visits in all adults with HF. 

The approval means Farxiga can now treat HF patients regardless of their left ventricular ejection fraction status. Previously, Farxiga was cleared in the U.S. to treat adults with HF with reduced ejection fraction (HFrEF).

For patients with HFrEF, the heart muscle doesn’t contract properly. For heart failure patients with preserved ejection fraction (HFpEF), the muscle contracts properly, but the ventricles don’t relax.

Both conditions affect the heart’s ability to pump enough blood.

Eli Lilly and Boehringer Ingelheim's Jardiance scored a similar approval last February, lapping Farxiga on the HF circuit.

The FDA based its approval on data from AZ’s phase 3 DELIVER study, which showed Farxiga slashed the risk of hospitalization and death from a CV event by 18% in patients with mildly reduced or preserved ejection fraction.

About half of the roughly 7 million heart failure patients in the U.S. suffer from mildly reduced ejection fraction or preserved ejection fraction, according to AstraZeneca.

Farxiga won its original FDA approval back in 2014 to treat Type 2 diabetes. It’s since expanded into kidney and heart diseases, winning a nod in 2019 to prevent HF in Type 2 diabetes patients. Despite Jardiance's early HF edge over Farxiga, AstraZeneca’s drug has been growing nicely across its triumvirate of indications. The drug scored a hefty $4.3 billion in global sales last year, growing 46% year over year. 

Farxiga has been building out its HF stake overseas, too. Earlier this year, the drug notched a win in Europe to treat patients suffering from HF with any type of left ventricular ejection fraction, including mildly reduced and preserved.