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FDA Approves New Drug for Treatment of Adults with Chronic Kidney Disease

Today, the U.S. Food and Drug Administration is working on oral Farxiga tablets to reduce the risk of renal dysfunction, renal failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of disease progression. Approved.

Chronic kidney disease is an important public health problem and there is a great unmet need for treatments that slow the progression of the disease and improve outcomes. Farxiga’s approval for the treatment of chronic kidney disease today is an important step in helping people living with kidney disease. “

Aliza Thompson, MD, MS, Deputy Director, Department of Cardiology and Nephrology, FDA Drug Evaluation and Research Center

Chronic kidney disease occurs when the kidneys are damaged and blood cannot be filtered properly. Due to this defective filtering, patients can develop complications related to the accumulation of fluids, electrolytes (minerals required for many body processes), and waste products in the body. Chronic kidney disease can progress to renal failure. Patients are also at increased risk of cardiovascular disease such as heart disease and stroke.

Effectiveness of Farxiga for improving renal outcomes and reducing cardiovascular death in patients with chronic kidney disease was evaluated in a multicenter, double-blind study. In this study, 4,304 patients were randomly assigned to receive either Farxiga or placebo. This study compared two groups for the number of patients who had at least 50% reduction in renal function, progression to renal failure, or disease progression to a composite (or composite) endpoint that included cardiovascular or renal death. .. The results showed that 197 of the 2,152 patients who received Farxiga had at least one of the composite endpoint events compared to 312 of the 2,152 patients who received placebo. Shown. This study compared two groups for the number of patients hospitalized for heart failure or died of cardiovascular disease. A total of 100 patients who received Farxiga were hospitalized or died, compared to 138 patients who received placebo.

Farxiga treats chronic renal disease in patients with autosomal dominant or recessive polycystic (characterized by multiple cysts) renal disease, or in patients who require or have recently used immunosuppressive therapy to treat renal disease. Has not been studied and is not expected to be effective.

Patients should not use Farxiga if they have a history of severe hypersensitivity to the drug or are on dialysis treatment. A serious, life-threatening case of Frunier’s Ganglene occurred in a diabetic patient taking Falxiga. Patients should consider low doses of insulin or insulin secretagogues to reduce the risk of hypoglycemia (hypoglycemia) if they are also taking Farxiga. Farxiga can cause dehydration, severe urinary tract infections, genital yeast infections, metabolic acidosis or ketoacidosis (accumulation of acid in the blood). Before starting Farxiga, the patient’s volumetric status and renal function should be evaluated.

Farxiga was initially approved in 2014 to improve glycemic control in adults with type 2 diabetes, in addition to diet and exercise.

Farxiga has received Fast Track, Breakthrough Therapy, and Priority Review designations for today’s approved indications. Fasttrack is designed to accelerate the development and review of drugs to treat serious conditions and meet unmet medical needs. Breakthrough therapy designations are designed to facilitate the development and review of drugs aimed at treating critical conditions, and preliminary clinical evidence is that the drug is clinically important. It shows that it may show a significant improvement over the treatments available at various endpoints. Prioritized review, when approved, with overall attention to the evaluation of drug applications that significantly improve the safety or efficacy of treatment, diagnosis, or prophylaxis of serious conditions when compared to standard applications. Direct resources.

The FDA has given AstraZeneca approval for Farxiga.

FDA Approves New Drug for Treatment of Adults with Chronic Kidney Disease

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