FDA clears Travere’s rare kidney disease drug, will come with REMS program
The FDA approved Travere Therapeutics’ treatment for a rare kidney disease on Friday, notching a win for the company after the review of the drug was delayed by three months last year.
The accelerated approval for sparsentan means Travere can now deliver the drug, which will be sold as Filspari, to patients with IgA nephropathy. In IgAN, or Berger’s disease, immunoglobulin builds up and disrupts the waste filtration process in the kidneys, which can lead to blood and protein in urine.
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