Novartis drug Fabhalta receives FDA approval
Published: Wednesday, Aug 7th 2024, 22:10
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The Novartis drug Fabhalta has received FDA approval for the reduction of proteinuria in patients with immunoglobulin A nephropathy (IgAN) who are at risk of rapid disease progression. This is according to information published on the website of the US regulatory authority on Wednesday evening.
This indication will be approved under accelerated approval based on the reduction of proteinuria, according to the FDA's prescribing information. It has not been proven whether Fabhalta slows the decline in kidney function in patients with IgAN.
"Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial," the FDA stated. IgAN is a kidney disease that affects around 25 million people worldwide every year. It is one of the main causes of chronic kidney disease.
One characteristic of the disease is proteinuria, i.e. the excretion of protein in the urine. Almost a third of patients suffering from proteinuria are at risk of suffering kidney failure within ten years and therefore require a transplant or are dependent on dialysis.
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