Travere Therapeutics drug Filspari received full FDA approval for treating the rare disease immunoglobulin A nephropathy (IgAN). The drug showed long-term benefits in slowing kidney function decline over two years. The approval removes a previous proteinuria threshold, expanding the eligible patient population to more than 70,000. Filspari is a small molecule that selectively blocks pathways associated with IgAN progression and is the only non-immunosuppressive therapy for the disorder. The drug still carries a black box warning for liver toxicity and is available under a Risk Evaluation and Mitigation Strategies (REMS) program. Sales are expected to increase with approvals in other markets.
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Full FDA Approval of Travere’s Kidney Drug Stiffens Competition With Novartis, Calliditas
