AstraZeneca drug approved by FDA for kidney disease treatment
pharmafile | May 4, 2021 | News story | Manufacturing and Production | AstraZeneca, FDA, kidney disease, pharma, pharma news
AstraZeneca’s Farxiga drug has been approved for the treatment of chronic kidney disease (CKD) in the US by the FDA.
The decision by the FDA was based on positive results from a Phase III trial, and follows the Priority Review designation granted earlier this year.
The DAPA-CKD Phase III trial demonstrated that Farxiga, on top of standard-of-care treatment, reduced the relative risk of worsening renal symptoms, onset of end-stage kidney disease, or risk of cardiovascular or renal death by 39%, compared to placebo. The drug also significantly reduced the relative risk of death from any cause by 31%.
Farxiga, otherwise known as dapagliflozin, is a first-in-class, oral, once-daily SGLT2 inhibitor. It is already used as an effective monotherapy and part of combination therapy in addition to diet and exercise to improve glycaemic control in adults with Type 2 diabetes.
CKD, a condition defined by decreased kidney function, is often associated with a heightened risk of heart disease or stroke, or the need for dialysis or kidney transplant. The disease is expected to become the fifth-leading cause of mortality globally by 2040, with 37 million people in the US estimated to have CKD currently.
Professor Hiddo L Heerspink, Co-Chair of the DAPA-CKD trial, said: “Based on the unprecedented results of the DAPA-CKD trial, dapagliflozin is now the first SGLT2 inhibitor approved for the treatment of chronic kidney disease regardless of diabetes status.
“This transformational milestone provides patients and physicians with a new and effective treatment option for this often debilitating and life-threatening disease.”
Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, added: “Today’s approval is the most significant advancement in the treatment of chronic kidney disease in more than 20 years.
“We’ve shown impressive efficacy for Farxiga in Type 2 diabetes, heart failure with reduced ejection fraction and, most recently, chronic kidney disease, and we are thrilled to be able to bring this medicine to millions of patients in the US.”
Jack Goddard
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