AstraZeneca gets another FDA nod for Farxiga

AstraZeneca announced on Friday that ‘Farxiga’ or dapagliflozin, has been granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) for patients with chronic kidney disease, with and without type-2 diabetes.

The FTSE 100 pharmaceuticals giant described chronic kidney disease as a “serious, progressive condition” defined by decreased kidney function, which is frequently associated with an increased risk of heart disease or stroke.

It noted that in the United States, 37 million people are estimated to have chronic kidney disease.

The FDA granted the designation based on clinical evidence from the ‘DAPA-CKD’ trial.

AstraZeneca said the detailed results presented in August demonstrated that Farxiga, on top of standard-of-care, reduced the composite measure of worsening of renal function or risk of cardiovascular or renal death by 39% compared to placebo in patients with chronic kidney disease, while also “significantly reducing” death from any cause by 31% compared to placebo.

It said the FDA's Breakthrough Therapy Designation is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need.

The new medicine needs to have shown encouraging early clinical results that demonstrate substantial improvement on a clinically-significant endpoint over available medicines.

“There is a serious, unmet need for better and earlier treatment options for patients with chronic kidney disease,” said executive vice-president of biopharmaceuticals research and development Mene Pangalos.

“Following the ground-breaking DAPA-CKD results, the Breakthrough Therapy Designation is further testament to Farxiga's potential to slow the progression of chronic kidney disease.

“We look forward to working with the FDA to make Farxiga available to patients as quickly as possible.”

In the US, Farxiga is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes, and to reduce the risk of hospitalisation for heart failure in patients with type-2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors.

In May, Farxiga was approved in the US to reduce the risk of cardiovascular death and hospitalisation and heart failure in adults with heart failure, with reduced ejection fraction with and without type-2 diabetes.

At 0842 BST, shares in AstraZeneca were down 0.57% at 8,431p.