British drug major AstraZeneca’s Farxiga (dapagliflozin) oral tablets can now be used in the United States to treat chronic kidney disease regardless of diabetes status.
The U.S. Food and Drug Administration approved Farxiga meant to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression.
According to the company, the approval is the most significant advancement in the treatment of chronic kidney disease in more than 20 years. Farxiga was originally approved in 2014 to improve glycemic control in adults with type 2 diabetes in addition to diet and exercise.
Chronic kidney disease occurs when the kidneys are damaged and cannot filter blood normally. Due to this defective filtering, patients can have complications related to fluid, electrolytes, which are minerals required for many bodily processes, as well as waste build-up in the body.
The disease sometimes can progress to kidney failure. Patients also are at high risk of cardiovascular disease, including heart disease and stroke.
The latest FDA approval was based on positive results from the DAPA-CKD Phase III trial that evaluated the efficacy of Farxiga to improve kidney outcomes and reduce cardiovascular death in patients with chronic kidney disease.
Farxiga received Fast Track, Breakthrough Therapy and Priority Review designations for the indication in the latest FDA approval.
Meanwhile, Farxiga was not studied and is not expected to be effective in treating chronic kidney disease among patients with autosomal dominant or recessive polycystic, characterized by multiple cysts, kidney disease or among patients who require or have recently used immunosuppressive therapy to treat kidney disease.
The company has also warned that patients who have a history of serious hypersensitivity reactions to the medication or if they are on dialysis treatment should not use Farxiga.
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