AstraZeneca said Tuesday that a Phase III study of Farxiga (dapagliflozin) in patients with reduced ejection fraction (HFrEF) on standard-of-care treatment, including those with and without type 2 diabetes, met its primary composite endpoint. The company noted that in the DAPA-HF trial, the oral once-daily SGLT2 inhibitor significantly reduced the risk of cardiovascular death or worsening of heart failure compared to placebo.
"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," remarked Mene Pangalos, executive vice president of biopharmaceuticals R&D. Pangalos added "we look forward to discussing the results…with health authorities as soon as possible."
Farxiga is currently approved as both monotherapy and as part of combination therapy to improve glycaemic control as an adjunct to diet and exercise in adults with type 2 diabetes. Sales of the product climbed 11% year-over-year in the second quarter to $377 million, fuelled by growth in China and Europe.
The DAPA-HF trial randomised HFrEF patients, with and without type-2 diabetes, to receive Farxiga or placebo, both given once daily in addition to standard of care, which includes medicines such as ACE inhibitors, angiotensin II receptor blockers, beta blockers, mineralocorticoid-receptor antagonists and neprilysin inhibitors. The study's primary composite outcome was time to a worsening heart failure event, defined as hospitalisation or an urgent heart failure visit, or cardiovascular death.
AstraZeneca indicated that the safety profile of Farxiga in the trial was consistent with its safety profile. Full results from the study will be submitted for presentation at an upcoming medical meeting. Farxiga is also being studied in patients with heart failure with preserved ejection fraction in the DELIVER and DETERMINE trials, in addition to chronic kidney disease in the DAPA-CKD study.
Commenting on the news, JP Morgan analysts said the "DAPA-HF study was seen as a 'wild-card' by the market, with a low probability of success, today being the first time a Phase III study has reported a heart failure benefit for an SGLT-2, in non-diabetic patients." The analysts estimated that the peak sales potential in this indication could exceed $900 million. Meanwhile, analysts at Liberum said the findings "will give the drug broad applicability and is strong validation of its utility, particularly in diabetics," adding that "the result will also reinforce Farxiga's utility in diabetes at a time when oral GLP-1 might enter the market."
Last month, the FDA issued a complete response letter regarding a filing seeking approval of Farxiga as an adjunct treatment to insulin to improve glycaemic control in adults with type 1 diabetes, when insulin alone does not provide adequate glycaemic control.
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