SAN DIEGO — Travere Therapeutics, a biotech focused both on treating rare diseases and distancing itself from controversial founder Martin Shkreli, on Friday won accelerated approval for a drug that treats IgA nephropathy, a rare and deadly autoimmune disease that attacks the kidneys and can lead to organ failure.
The drug, which will be sold under the name Filspari, is a once-a-day oral tablet that comes in 200-milligram and 400-milligram doses. The Food and Drug Administration granted accelerated approval after interim results from an ongoing Phase 3 clinical trial found that the treatment significantly reduced protein levels in the urine of patients, an indirect marker of improved kidney function.
But after news of the approval — and that the drug’s label would include a hefty set of “black box” warnings, the FDA’s strictest safety concerns — shares of San Diego-based Travere dropped a bit over 12%, closing at $17.82.
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