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Travere Positioned To Seek Accelerated Approval In Rare Kidney Disorder

 
• By Joseph Haas

With interim Phase III data showing threefold reduction in proteinuria reduction compared to SOC, Travere plans to seek accelerated US and EU approval of sparsentan in immunoglobulin A nephropathy.

Human kidney on scientific background. 3d illustration
Travere's sparsentan is one of several candidates to be the first approved IgAN therapy

Travere Therapeutics, Inc. said it plans to seek accelerated approval in the US for sparsentan in immunoglobulin A nephropathy (IgAN) early in 2022, after data from a prespecified interim look at the Phase III PROTECT study showed that the dual angiotensin II/endothelin A receptor antagonist reduced proteinuria levels threefold compared to standard-of-care at 36 weeks.

The San Diego firm, known as Retrophin until last fall, also said on 16 August that the drug showed no new safety signals in the ongoing pivotal study, which will continue and hopefully provide confirmation of clinical

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