AZ claims first-in-class win for Farxiga in heart failure

AstraZeneca has moved a step close to a chronic heart failure claim for its diabetes drug Farxiga after reporting positive results in a phase 3 trial.

The phase 3 DAPA-HF trial has shown that SGLT2 inhibitor Farxiga (dapagliflozin) was able to reduce cardiovascular death or the worsening of hearty failure, compared to placebo, in heart failure patients with reduced ejection fraction (HFrEF).

Farxiga was added to standard treatment in the study, and according to AZ is the first SGLT2 inhibitor to show a benefit in both diabetic and non-diabetic HFrEF patients.

Farxiga is already growing quickly for AZ on the back of new data showing it can reduce cardiovascular and kidney complications in diabetes patients, but a heart failure claim could add to its momentum by extending its use beyond diabetes.

Sales grew by a third to $1.4bn last year as Farxiga tries to chase down SGLT2 market leader Jardiance (empagliflozin) from Eli Lilly and Boehringer Ingelheim, which brought in around $2.7bn for the two partners in 2018 after becoming the first drug in the class to show an impact on cardiovascular outcomes.

At the same time, first-to-market SGLT2 inhibitor Invokana (canagliflozin) from Johnson & Johnson has been shrinking since the FDA added a label warning of lower-limb amputations risk in 2017.

Boehringer and Lilly have their own aspirations for a CHF label claim, and have just won a fast-track review from the FDA for Jardiance in both HFrEF and heart failure with preserved ejection fraction (HFpEF) based on two trials - EMPEROR-Reduced and EMPEROR-Preserved – that are due to read out next year.

The two partners also have another pair of trials under the EMPERIAL banner looking at exercise capacity and heart failure symptoms that are due to generate results before the end of this year.

Meanwhile, Farxiga is also being studied in HFpEF in the DELIVER trial as well as the DETERMINE study, which is enrolling both HFrEF and HFpEF patients. Those trials are also due to read out next year.

AZ has only revealed the top-line data from DAPA-HF, but for now seems to be in pole position for a heart failure claim for Farxiga in diabetic and non-diabetic HFrEF, and shares rose almost 2% this morning on the back of the announcement.

Mene Pangalos

The company’s head of biopharma R&D, Mene Pangalos, said that at the moment “half of heart failure patients will die within five years of diagnosis and it remains one of the leading causes of hospitalisation.”

“We look forward to discussing the results of DAPA-HF with health authorities as soon as possible,” he added.