AstraZeneca's diabetes drug Farxiga helps patients with heart disease and without diabetes in landmark trial
Months ago, data on J&J’s $JNJ Invokana indicated the diabetes drug conferred cardiovascular (CV) benefit in patients who do and do not have preexisting CV disease. On Tuesday, AstraZeneca’s $AZN rival treatment, Farxiga, was shown to cut the risk of CV death or the worsening of heart failure in patients with heart disease, in a landmark trial.
The treatments, in addition to Jardiance from Eli Lilly $LLY, belong to a class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination.
Patients with diabetes are often afflicted with other comorbidities, such as obesity, CV disease and kidney problems. SGLT2 makers have been vying for bigger market share by differentiating their drugs on the basis of therapeutic impact on renal impairment — but the major, most lucrative battleground is the heart.
Data presented on Tuesday came from the 4,744-patient DAPA-HF trial, which tested Farxiga in patients with reduced ejection fraction (HFrEF) — in which the heart muscle is not able to contract amply and, therefore, expels less oxygen-rich blood into the body — on standard of care treatment, including those with and without type-II diabetes.
The drug met the main goal of conferring a statistically-significant and clinically-meaningful reduction of cardiovascular death or the worsening of heart failure (defined as hospitalization or an urgent heart failure visit), compared to placebo, AstraZeneca said.
Further trial details will be presented at a later date, and the British drugmaker is set to talk to health authorities about the results, the company said.
“With the DAPA-HF trial, Farxiga becomes the first in its class to demonstrate efficacy and safety data for the treatment of patients with heart failure, with and without type-2 diabetes, on top of standard of care,” said Mene Pangalos, executive VP of BioPharmaceuticals R&D. “Today, half of heart failure patients will die within five years of diagnosis and it remains one of the leading causes of hospitalisation.”
Last year, AstraZeneca presented mixed data on Farxiga from a large study in type-II diabetes patients at risk for CV disease or established CV disease. In the DECLARE-TIMI 58 trial, which included more than 17,000 patients, Farxiga met one of the main goals by conferring a statistically-significant reduction in the composite endpoint of hospitalization for heart failure or CV death. But it failed to clear the co-primary endpoint of reducing major adverse cardiovascular events (MACE) versus placebo.
Farxiga, whose sales underwhelmed analyst expectations in the second quarter, is also being developed for patients with heart failure in the DELIVER (HFpEF) and DETERMINE (HFrEF and HFpEF) trials, in addition to chronic kidney disease in the DAPA-CKD trial. Its rivals are testing their diabetes offerings in a range of heart and kidney trials as well.