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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