STAT+: First non-immunosuppressive drug approved for a rare and deadly kidney disease

SAN DIEGO — Travere Therapeutics, a biotech focused both on treating rare diseases and distancing itself from controversial founder Martin Shkeli, 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.

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