AstraZeneca’s Farxiga has become the first drug in the SGLT2 inhibitor class to be approved in the US to reduce the chances of hospitalisations for heart failure in adults with type 2 diabetes and other cardiovascular risks.
The FDA approval comes on the back of the DECLARE-TIMI 58 clinical trial, which showed that Farxiga (dapagliflozin) was able to reduce hospitalisations for heart failure and cardiovascular death in a broad diabetes patient population, most of whom had no cardiovascular disease at enrolment, compared with placebo.
The FDA approval comes shortly after the same indication was approved in Europe (where the drug is sold as Forxiga), and should add further momentum to what is already strong sales growth on the back of data from DECLARE-TIMI-58 showing it can reduce cardiovascular and kidney complications in diabetes patients.
Farxiga is also under regulatory review in China to reduce hospitalisations for heart failure in diabetics, with a decision expected in the first half of 2020.
“This is promising news for the 30 million people living with type 2 diabetes in the US, as heart failure is one of the earliest cardiovascular complications for them, before heart attack or stroke,” said Ruud Dobber, executive vice president of biopharmaceuticals at AZ.
It’s also an important win for AZ as it tries to chase down SGLT2 inhibitor market leader Jardiance (empagliflozin) from Eli Lilly and Boehringer Ingelheim.
Farxiga brought in $1.4bn in sales for the company last year, just over half the $2.7bn made by Jardiance which was the first drug in the SGLT2 inhibitor to get labelling approved for reducing cardiovascular outcomes in diabetes.
The approval is something of a stepping stone for another potential new indication – treating heart failure with reduced ejection fraction (HFrEF) in both diabetic and non-diabetic patients – which would be an even bigger market opportunity for the drug as it enters its last few years of patent life.
The HFrEF trial, called DAPA-HF, was presented at this year’s European Society of Cardiology (ESC) congress in Paris to some fanfare, showing that Farxiga reduced the composite of cardiovascular (CV) death or worsening of heart failure by 26% when added to standard therapy.
At the ESC, DAPA-HF was described as a “landmark trial” that could usher in “a new era in heart failure medical treatment”. In the meantime AZ is running another study to see if the HFrEF results can be matched in heart failure with preserved ejection fraction (HFpEF), a hard-to-treat form of the disease that currently has no approved drug therapies, which is due to read out next year.
Boehringer and Lilly are testing Jardiance in both HFrEF and HFpEF with two trials – EMPEROR-Reduced and EMPEROR-Preserved – also due to generate results in 2020.