AstraZeneca's Forxiga recommended for EU approval

AstraZeneca said on Monday that ‘Forxiga’, or dapagliflozin, has been recommended for approval in the European Union for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D).

The FTSE 100 pharmaceuticals giant said the recommendation by the Committee for Medicinal Products for Human Use (CHMP) was based its positive opinion on results from the ‘DAPA-CKD’ phase 3 trial that showed Forxiga, on top of standard-of-care treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the risk of the composite of worsening of renal function, end-stage kidney disease and cardiovascular or renal death, compared to placebo.

It also significantly reduced the risk of death from any cause, compared to placebo, the company added.

In the trial, the safety and tolerability of Forxiga were consistent with the “well-established” safety profile of the medicine.

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

It affects around 47 million people in the EU and nearly 840 million people worldwide, but diagnosis rates remain low and up to 90% of patients remain unaware they have the disease.

“The unprecedented results of the DAPA-CKD phase 3 trial show that Forxiga can significantly slow the decline of kidney function and reduce the risk of death for patients with chronic kidney disease,” said Mene Pangalos, executive vice-president of biopharmaceuticals research and development.

“This positive CHMP opinion underscores Forxiga's potential to transform the future care of chronic kidney disease and brings us one step closer to providing a much-needed new treatment option to millions of patients in the EU.”

Forxiga, known as Farxiga in the United States market, was recently approved in the US for the treatment of CKD in adults with and without T2D and, in addition to the EU, was currently under review in Japan and other countries.

AstraZeneca said Forxiga is also indicated as an adjunct to diet and exercise to improve glycaemic control in adults with T2D, and for the treatment of symptomatic chronic heart failure with reduced ejection fraction in adults with and without T2D.

At 0823 BST, shares in AstraZeneca were up 0.64% at 8,553p.