European Commission converts conditional approval of FILSPARI (sparsentan) into standard marketing authorization for the treatment of IgA Nephropathy (IgAN)
CSL Vifor and Travere Therapeutics, Inc. are pleased to announce that the European Commission has approved the conversion of the conditional marketing approval (CMA) into a standard marketing authorization (MA) for FILSPARI for the treatment of adults with primary IgA nephropathy with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). Standard MA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.
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“The decision by the European Commission is an important advancement for people living with IgAN in the EU”, said Dr. Vinicius Gomes De Lima, Head of Global Medical Affairs at CSL Vifor. “The standard approval, granted without changes to the indication, underscores the value of our clinical data, the dedication of our teams, and our ongoing commitment to deliver on our promise for patients. We look forward to continuing working closely with healthcare professionals, patient communities, and regulatory bodies to ensure access to FILSPARI across Europe.”
The European Commission’s standard approval of FILSPARI is a meaningful step forward for people living with IgA nephropathy across Europe,” said Dr. Jula Inrig, Chief Medical Officer at Travere Therapeutics. “This decision not only validates the strength of the phase-III PROTECT study results but also reinforces our deep commitment to this rare kidney disease community. We remain dedicated to working with our partners, regulators, and healthcare providers to expand access and improve outcomes for those affected by IgAN.”
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The European Commission’s decision follows CHMP’s recommendation to convert the CMA to standard MA from February 2025. The approval is based on a comprehensive clinical data set, including positive confirmatory results from the pivotal phase-III PROTECT study demonstrating that FILSPARI significantly slowed kidney function decline over two years compared to irbesartan.
FILSPARI is the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA), a non-immunosuppressive therapy for the treatment of IgAN approved in Europe and is currently available in Germany, Austria and Switzerland, following the European Commission’s conditional marketing authorization in April 2024
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Source – PR Newswire
