Travere Therapeutics, Inc.. stands to significantly expand and potentially even double the addressable patient population for its immunoglobulin A nephropathy (IgAN) drug Filspari (sparsentan) with the US Food and Drug Administration granting it full approval. A draft guideline from Kidney Disease Improving Global Outcomes (KDIGO) should serve as a tailwind for uptake as well.
The FDA granted Filspari the full approval on 5 September, expanding the label to make the drug available to patients with IgAN at risk of progression, with data showing long-term benefit on proteinuria and kidney function over two years, based on results of the confirmatory Phase III PROTECT trial. The FDA gave the drug accelerated approval in February 2023
Key Takeaways
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The FDA granted full approval to Filspari, removing the proteinuria threshold and thus expanding the addressable patient population.
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Travere expects the population to go from 30,000-50,000 to more than 70,000, with potentially further expansion as well
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