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FDA sets back Travere’s plans for kidney disease drug approval

May 26, 2021


The FDA has crushed Travere Therapeutics’ hopes of seeking accelerated approval in a rare kidney disorder on the strength of existing interim data from a phase 3 clinical trial. Travere said it may have enough data to meet the FDA’s demands by the first half of next year.

In February, Travere, the rebranded form of Martin Shkreli-founded Retrophin, said a phase 3 trial of endothelin receptor antagonist sparsentan in focal segmental glomerulosclerosis (FSGS) met its pre-specified interim partial remission of proteinuria endpoint after 36 weeks of treatment. Based on the data, Travere set out to seek accelerated approval in the U.S. and EU.

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