AstraZeneca gets another approval for 'Forxiga'

The FTSE 100 pharmaceuticals giant said the approval by the European Commission was based on positive results from the ‘DAPA-CKD’ phase 3 trial, and followed a recommendation for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use.

AstraZeneca described CKD as a “serious, progressive condition” defined by decreased kidney function, and was often associated with an increased risk of heart disease or stroke.

It said it affects 840 million people globally, and approximately 47 million in the EU, but diagnosis rates remained low and up to 90% of patients were unaware they had the disease.

The DAPA-CKD phase 3 trial demonstrated that Forxiga, on top of standard-of-care treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the relative risk of worsening of renal function, onset of end-stage kidney disease, or risk of cardiovascular or renal death by 39% compared to placebo in patients with CKD stages two to four, and elevated urinary albumin excretion.

Forxiga also significantly reduced the relative risk of death from any cause by 31% compared to placebo.

The safety and tolerability of Forxiga was consistent with the well-established safety profile of the medicine.

Forxiga, known as Farxiga in the United States, was recently approved in the US for the treatment of CKD in adults with and without type-2 diabetes, and was currently under review in Japan and a number of other countries around the world.

It is also indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes, and for the treatment of symptomatic chronic heart failure with reduced ejection fraction in adults, regardless of diabetes status.

“Today's approval is an important milestone for Forxiga and has the potential to transform treatment for the millions of people living with chronic kidney disease in the EU,” said AstraZeneca’s executive vice-president of biopharmaceuticals research and development, Mene Pangalos.

“While new medicines like Forxiga advance the standard of care, we are also committed to the prevention and early detection of this often debilitating and life-threatening disease.”

At 0824 BST, shares in AstraZeneca were up 0.56% at 8,201p.