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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