AstraZeneca gets another approval for 'Farxiga'

AstraZeneca said on Wednesday that ‘Farxiga’, or dapagliflozin, has been approved in the United States to reduce the risk of cardiovascular death and hospitalisation for heart failure in adults with heart failure with reduced ejection fraction, with and without type-2 diabetes.

The FTSE 100 pharmaceuticals giant said the approval by the Food and Drug Administration was based on positive results from the landmark phase 3 ‘DAPA-HF’ trial, which showed Farxiga achieving a “statistically significant and clinically meaningful” reduction in cardiovascular death or hospitalisation for heart failure, compared to placebo.

It said the decision followed the priority review designation granted by the FDA earlier in the year, and the ‘Fast Track’ designation granted in September.

Farxiga is the first sodium glucose co-transporter 2 inhibitor approved by the US FDA, indicated to treat patients with heart failure with reduced ejection fraction.

“With the approval of Farxiga, we have reached a critical milestone to potentially transform heart failure treatment for the millions of people living with the condition in the US,” said executive vice-president of biopharmaceuticals research and development, Mene Pangalos.

“We are now one step closer to making a significant impact on their lives by providing a much-needed treatment to help reduce their disease burden and live longer.”

AstraZeneca said the DAPA-HF trial showed that Farxiga, in addition to standard of care, reduced the risk of the composite outcome of cardiovascular death or the worsening of heart failure versus placebo by 26% in patients with heart failure with reduced ejection fraction.

During the trial, one cardiovascular death or hospitalisation for heart failure, or an urgent visit associated with heart failure, could be avoided for every 21 patients treated with Farxiga.

It said the safety profile of Farxiga in the DAPA-HF trial was consistent with the “well-established” safety profile of the medicine.

The data from the trial was published in the New England Journal of Medicine.

In October, the US FDA approved Farxiga to reduce the risk of hospitalisation for heart failure in adult patients with type-2 diabetes, and established cardiovascular disease or multiple cardiovascular risk factors.

That approval was based on the ‘DECLARE-TIMI 58’ trial.

Farxiga is also indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes.

“The ground-breaking results of the DAPA-HF trial have transformed heart failure therapeutics,” said John McMurray of the Cardiovascular Research Centre at the University of Glasgow’s Institute of Cardiovascular and Medical Sciences.

“Today's approval provides physicians with a completely novel pharmacological approach that greatly improves outcomes for patients with heart failure with reduced ejection fraction.”

At 1086 BST, shares in AstraZeneca were up 1.32% at 8,624p.