Clinical ValidationFILSPARI significantly slowed kidney function decline over two years compared to active control ARB, irbesartan, thereby confirming and validating the initial approval and the overall PROTECT study.
FDA ApprovalThe full approval and updated drug label, together with the inclusion of Filspari into the Guidelines, generates a strong opportunity for an additional increase in sales revenue.
Market ExpansionRemoving the proteinuria threshold is critical, as it nearly doubles the TAM of FILSPARI for IgAN in the U.S. to over 70,000 patients, from 30,000-50,000 previously.