AstraZeneca's Dapagliflozin (Farxiga) Meets All Primary and Secondary Endpoints in Pivotal Phase III DAPA-CKD Trial for Chronic Kidney Disease

Today, AstraZeneca announced that its SGLT2 inhibitor dapagliflozin (brand name Farxiga) met all primary and secondary endpoints in a Phase 3 clinical trial evaluating the treatment of patients with chronic kidney disease (CKD). Results from the DAPA-CKD trial demonstrated that dapagliflozin produced statistically significant and clinically meaningful improvements in the composite endpoint among adult patients with CKD. This composite endpoint comprised worsening of renal function, progression to end-stage kidney disease (ESKD), and cardiovascular (CV) or renal death. The trial also met all its secondary endpoints in CKD patients both with and without type 2 diabetes. According to the press release, this means that dapagliflozin is the first drug to significantly reduce the risk of all-cause mortality in this patient population.

Chronic kidney disease (CKD) is a severe, progressive condition affecting nearly 700 million people worldwide. Currently, treatment options for these patients are limited. CKD is associated with a significantly increased risk of cardiovascular events, such as heart failure (HF) and premature death.

Dapagliflozin is a “first-in-class” oral SGLT2 inhibitor. SGLT2 is a transporter protein in the kidneys that facilitates glucose reabsorption. By inhibiting SGLT2 function, SGLT2 inhibitors promote the excretion of more glucose into the urine, thereby lowering blood glucose levels. It has been approved by the U.S. FDA to improve glycemic control in patients with type 2 diabetes, when used in conjunction with diet and exercise, and can also reduce body weight and blood pressure. It has also received approval in the European Union for the treatment of patients with type 1 diabetes. Last August, the FDA granted dapagliflozin Fast Track designation to delay the progression of renal failure and prevent cardiovascular disease and renal failure in patients with chronic kidney disease (CKD).

DAPA-CKD was an international, multicenter, randomized, double-blind Phase 3 clinical trial involving 4,245 patients. It aimed to evaluate the efficacy of dapagliflozin versus placebo in patients with stage 2–4 chronic kidney disease (CKD), regardless of whether they had type 2 diabetes (T2D). In March this year, AstraZeneca announced that, based on recommendations from the independent Data Monitoring Committee (DMC), dapagliflozin demonstrated highly significant therapeutic effects in CKD patients. As patients achieved clinical benefits earlier than expected, the Phase 3 trial was terminated early. Detailed data from the trial will be presented at future medical conferences.

References:

[1] FARXIGA Met All Primary and Secondary Endpoints in Groundbreaking Phase III DAPA-CKD Trial for the Treatment of Patients With Chronic Kidney Disease. Retrieved July 28, 2020, from https://www.businesswire.com/news/home/20200728005496/en

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