AstraZeneca's Farxiga Receives EU Approval for Chronic Kidney Disease in Patients With and Without Type 2 Diabetes

Compiled by | Tom Li

Recently, AstraZeneca’s SGLT2 inhibitor Forxiga (dapagliflozin) has been approved by the European Commission (EC) for the treatment of adult patients with newly diagnosed or worsening chronic kidney disease (CKD), with or without type 2 diabetes (T2D). This drug has also become the first SGLT2 inhibitor approved in the EU for the treatment of CKD. Additionally, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted an extended license for Forxiga in the UK.

The European Commission's approval of Forxiga was primarily based on the positive results of the Phase 3 DAPA-CKD trial, following the approval recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Conducted across 21 countries, the DAPA-CKD trial is a multicenter, randomized, double-blind, late-stage clinical trial. The trial aimed to evaluate the effects of Forxiga 10 mg versus placebo, both added to standard of care, on renal outcomes and cardiovascular mortality in patients with chronic kidney disease (with or without type 2 diabetes). The DAPA-CKD trial enrolled a total of 4,245 patients.

Trial results demonstrated that, when added to standard therapy with angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), Forxiga further reduced the relative risk of worsening kidney function and progression to end-stage kidney disease. Compared with placebo, in patients with chronic kidney disease (CKD) stages 2 to 4 and elevated urinary albumin excretion, Forxiga reduced the risk of cardiovascular or renal death by 39%, with an absolute risk reduction (ARR) of 5.3%.

Additionally, the study also met all secondary endpoints. Compared with placebo, Forxiga significantly reduced the relative risk of all-cause mortality by 31%. In the trial, the safety and tolerability of Forxiga were consistent with its previously established safety profile. Fewer serious adverse events occurred in the Forxiga group compared with the placebo group (29.5% vs. 33.9%, respectively). No cases of diabetic ketoacidosis were reported in the Forxiga group, whereas 2 cases were reported in the placebo group. Based on the positive results of this trial, Forxiga is the first drug to significantly prolong survival in a renal outcome trial involving CKD patients with and without type 2 diabetes.

In a statement, AstraZeneca said the approval of Forxiga marks the first new therapy for chronic kidney disease in adults in the EU in nearly 20 years. As a first-in-class, once-daily oral selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, Forxiga lowers blood glucose independently of insulin by selectively inhibiting SGLT2 in the kidneys, helping patients excrete excess glucose in the urine. In addition to glucose lowering, the drug offers additional therapeutic benefits such as weight loss and blood pressure reduction.

Forxiga was recently approved in the United States for the treatment of adult patients with new-onset or worsening chronic kidney disease (CKD), with or without type 2 diabetes (T2D). The drug is currently under review in Japan and several other countries and regions worldwide. In addition, Forxiga is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, and for the treatment of symptomatic chronic heart failure with reduced ejection fraction in adults. In 2017, the drug was approved in China to improve glycemic control in adult patients with type 2 diabetes.

Reference Source:

1.AstraZeneca gets another approval for 'Forxiga'

2.AZ’s Forxiga gains EC, MHRA approvals for chronic kidney disease

3.Forxiga approved in the EU for the treatment of chronic kidney disease in patients with and without type-2 diabetes