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Friday, May 24, 2024

FDA approves new treatment indication of Dapagliflozin for chronic kidney disease in adults

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AstraZeneca’s Dapagliflozin has been approved by the Food and Drug Administration for its new indication for the treatment of Chronic Kidney Disease (CKD) in adults with or without Type 2 Diabetes.

This approval was based on the DAPA-CKD trial which showed benefits in slowing down the progression of CKD, decreasing the likelihood of end-stage kidney disease and death.

Studies have shown that one Filipino develops CKD every 40 minutes, and one Filipino CKD patient progresses to dialysis every hour.

Impaired kidney function remains to be one of the highest causes of death and disability in the Philippines according to recent data, and Chronic Kidney Disease has been identified as a leading cause of premature death among Filipinos.

Renal dialysis cases across the Philippines have steadily climbed over the past few years, signifying the rise of kidney-related patients.

Globally, CKD had been recognized as an emerging public health issue, with an estimate of 1.4 million deaths around the world in 2019. The same report also claimed that this increasing number might be due to the rise of CKD risk factors such as diabetes, hypertension, obesity, and other heart-related diseases.

According to nephrologist Dr. Nickson Austria: “As the burden of CKD weighs heavier on patients’ shoulders, it’s very important to have these initiatives from the WKD committee and AstraZeneca to bring more attention to the issue, and hopefully bring us closer to solutions and treatments.”

“The success of the DAPA-CKD trial provides patients with additional treatment options to treat CKD and improve quality of life. This breakthrough is a very important milestone and we are eager to share with the Filipino community. We hope that with discoveries like this the stigma of chronic kidney disease will be a thing of the past,” said Dr. Rey Isidto, a nephrologist and the National Lead Investigator for DAPA-CKD8.

In the Philippines, Dapagliflozin is approved for glycemic control and for the prevention of new or worsening hospitalization for heart failure or cardiovascular death and nephropathy in adult patients with Type 2 Diabetes and approved for the treatment of heart failure with reduced ejection fraction in adult patients. It is now approved in adults for the treatment of Chronic Kidney.

“AstraZeneca believes that every Filipino deserves a good quality of life despite diseases such as Chronic Kidney Disease. Through education on early prevention and management, we hope to curb the worsening mortality rate from CKD and provide patients with better access to information and care. The recent approval of Dapagliflozin for patients with CKD is a concrete example of our longstanding commitment to innovation and Filipino healthcare,” said Lotis Ramin, country president of AstraZeneca Philippines.  

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