EMA Committee Recommends Approval For AstraZenecas Forxiga To Treat Chronic Kidney Disease

AstraZeneca’s Forxiga (dapagliflozin) has been recommended for approval in the European Union (EU) for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D).The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the DAPA-CKD phase III 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 (ESKD) and cardiovascular (CV) or renal death, compared to placebo.Forxiga also significantly reduced the risk of death from any cause, compared to placebo. In the trial, the safety and tolerability of Forxiga were consistent with the well-established safety profile of the medicine.CKD is a serious, progressive condition defined by decreased kidney function and is often associated with an increased risk of heart disease or stroke. It affects approximately 47 million people in the EU and nearly 840 million people worldwide. However, diagnosis rates remain low and up to 90% of patients are unaware they have the disease.Mene Pangalos, executive vice president, BioPharmaceuticals R&D, said: “The unprecedented results of the DAPA-CKD phase III trial show that Forxiga can significantly slow the decline of kidney function and reduce the risk of death for patients with chronic kidney disease. 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 US) was recently approved in the US for the treatment of CKD in adults with and without T2D and, in addition to the EU, is currently under review in Japan and other countries around the world. 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 (HF) with reduced ejection fraction (HFrEF) in adults with and without T2D.DAPA-CKD was an international, multi-centre, randomised, double-blinded Phase III trial in 4,304 patients designed to evaluate the efficacy of Forxiga 10mg, compared with placebo, in patients with CKD Stage and elevated urinary albumin excretion, with and without T2D. Forxiga was given once daily in addition to standard of care. The primary composite endpoint was worsening of renal function or risk of death (defined as a composite of an eGFR decline =50%, onset of ESKD or death from CV or renal cause).Forxiga (dapagliflozin) is a first-in-class, oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor. The research for Forxiga is advancing from cardiorenal effects to prevention and organ protection as science continues to identify the underlying links between the heart, kidneys and pancreas. Damage to one of these organs can cause the other organs to fail, contributing to leading causes of death worldwide, including T2D, HF and CKD.For nearly a decade Forxiga has been an effective monotherapy and part of combination therapy as an adjunct to diet and exercise to improve glycaemic control in adults with T2D. Following results from the landmark DECLARE-TIMI 58 phase III CV outcomes trial, it is approved in adults with T2D to reduce the risk of hHF or CV death when added to standard of care. Forxiga is also the first SGLT2 inhibitor approved for the treatment of HFrEF in adults with and without T2D.

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