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Today, the U.S. Food and Drug Administration accepted Farxiga (dapagliflozin) oral tablets to decrease 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.
Chronic kidney disease occurs when the kidneys are damaged and can’t filter blood normally. Because of this faulty coughing, patients can have complications associated with fluid, electrolytes (minerals required for many physiological processes), and waste build-up within the body. Chronic kidney disease occasionally can progress to kidney failure.
The efficacy of Farxiga to improve kidney outcomes and reduce cardiovascular death in patients with chronic kidney disease was evaluated in a multicenter, double-blind study. The study compared the two groups for the number of patients whose disease progressed to a composite (or combined) endpoint that included at least a 50% reduction in kidney function, progression to kidney failure, or kidney or cardiovascular death. Results showed that 197 of those 2,152 patients who received Farxiga had at least one of the composite endpoint events compared to 312 of the 2,152 patients that received a placebo. The study also compared the two groups for the number of patients who were hospitalized for heart failure or died from cardiovascular disease.
Patients should not use Farxiga if they have a history of serious hypersensitivity reactions to the medication or if they are on dialysis treatment. Serious, life-threatening cases of Fournier’s Gangrene have happened in patients with diabetes taking Farxiga. Patients should consider a lower dose of insulin or insulin secretagogue to reduce the risk of hypoglycemia (low blood glucose ) if they’re also taking Farxiga. Farxiga can cause dehydration, serious urinary tract infections, genital yeast infections, and metabolic acidosis or ketoacidosis (acid build-up from the blood). Patients should be assessed for their volume status and kidney function before starting Farxiga.
Farxiga was initially approved in 2014 to improve glycemic control in adults with type 2 diabetes in addition to diet and exercise.
Farxiga received Fast Track, Breakthrough Therapy and Priority Review designations for the sign being approved now. Fast track is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need. Breakthrough therapy designation is intended to expedite the development and review of drugs which are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). Priority review directs overall attention and resources to the analysis of applications for drugs that, if approved, would be significant improvements in the safety or efficacy of the treatment, diagnosis or prevention of severe conditions when compared to conventional applications.
The FDA granted the approval of Farxiga to AstraZeneca.
Source:
U.S. Food and Drug Administration
