Eric Dube, Travere Therapeutics CEO

FDA punts Travere's rare kid­ney dis­ease NDA for three months, re­quest­ing REMS up­date

A for­mer Mar­tin Shkre­li biotech is at the FDA’s gates for its lead can­di­date, but it’s go­ing to have to wait a bit longer for the reg­u­la­tor’s de­ci­sion.

Tra­vere Ther­a­peu­tics, for­mer­ly known as Retrophin and found­ed in 2011 by the in­fa­mous “Phar­ma Bro,” put out word Thurs­day that it ex­pects the PDU­FA date for its lead can­di­date, sparsen­tan in IgA neu­ropa­thy, to be pushed out an­oth­er three months to Feb­ru­ary. The drug, a dual an­tag­o­nist of both en­dothe­lin and an­giotensin, is cur­rent­ly un­der re­view by the FDA in two dif­fer­ent kid­ney dis­ease in­di­ca­tions: IgA nephropa­thy (where an an­ti­body called im­munoglob­u­lin A builds up in the kid­neys) and FS­GS, which caus­es scar­ring on the kid­neys.

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