2022-09-05| Trials & Approvals

AstraZeneca’s Treatment for Chronic Kidney Disease Wins Yet Another Approval

by Max Heirich
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On September 5, AstraZeneca announced that China’s National Medical Products Administration (NMPA) approved Forxiga (dapagliflozin). Forxiga is an inhibitor to prevent various conditions in patients with chronic kidney disease (CKD). The NMPA decided based on data from the DAPA-CKD Phase 3 trial. 

Related Article: Ocelot’s Rare Kidney Disease Candidate Receives Orphan Drug Designation Going Into Phase 2 Trials

What Conditions Does Forxiga Prevent?

CKD is a serious condition wherein the body’s kidneys cannot filter blood as efficiently as they should due to lasting damage. The primary causes of CKD are diabetes and high blood pressure, which lead to lasting kidney damage.

Due to the lack of efficiency in filtering blood, many additional conditions spawn from CKD. The lack of efficiency puts more strain on a patient’s heart, leading to a high risk of heart failure, the leading cause of death in the United States. In addition, CKD can eventually lead to end-stage renal disease (ESRD), in which the kidneys cease functioning altogether. As a result, patients must live off dialysis or receive an entire kidney transplant to survive.

Currently, treatments for CKD mostly consist of treatments for the disease’s complications. These include high blood pressure medications, medications to relieve swelling, medications to treat anemia, medicines to lower cholesterol levels, and medications to protect your bones. 

On the other hand, Forxiga works slightly differently. Rather than directly treating the symptoms of CKD, it prevents the development of additional conditions. Forxiga is a sodium-glucose co-transporter-2 (SGLT2) inhibitor. It blocks the SGLT2 protein, a protein responsible for glucose reabsorption, in a patient’s kidneys. As a result, the body removes glucose, sodium, and water via urine. 

A Phase 3 Trial Wins Forxiga’s Approval

DAPA-CKD was a Phase 3 trial comparing the efficacy of Forxiga to a placebo. Four thousand three hundred four patients with CKD Stage 2-4 with or without Type-2 Diabetes participated in the study. Worsening of renal function or risk of death was the primary endpoint. The secondary endpoint included time to the first occurrence of the renal composite, the composite of CV death or hospitalization for heart failure, and death from any cause.

The results, published in The New England Journal of Medicine, demonstrated that instances of complications or death were 39% lower in patients taking Forxiga than the placebo. In addition, results between patients with Type-2 Diabetes and those without remained consistent. The results of this study won the approval of China’s NMPA.

On the approval, Sir Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca, said, “…this approval marks another important step forward in our ambition to stop, reverse and ultimately cure chronic kidney disease globally. We are thrilled at the opportunity to bring Forxiga to millions of patients across the country and improve patient outcomes.”

This approval falls in line with the United States Food and Drug Administration’s (FDA) approval on April 30, 2021, under the name Farxiga. With approvals in 100 countries around the globe, Forxiga seems poised to become a standard of care for patients with CKD.

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