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Highlights

  • European Commission grants standard MA for FILSPARI in primary IgA nephropathy treatment.
  • The approval covers all EU member states, along with Iceland, Liechtenstein, and Norway.
  • FILSPARI's approval based on positive results from the phase-III PROTECT study.

The European Commission has approved the conversion of the conditional marketing approval (CMA) for FILSPARI into a standard marketing authorization (MA) for the treatment of primary IgA nephropathy (IgAN) in adults with a urine protein excretion of ≥1.0 g/day. This authorization applies across all EU member states, as well as Iceland, Liechtenstein, and Norway.

The decision follows the recommendation from the Committee for Medicinal Products for Human Use (CHMP) earlier this year, and it is supported by the results of the pivotal phase-III PROTECT study. The study demonstrated that FILSPARI significantly slowed kidney function decline compared to irbesartan, highlighting its potential in managing IgAN, a rare kidney disease.

Dr. Vinicius Gomes De Lima, Head of Global Medical Affairs at CSL Vifor, expressed that the approval underscores the value of their clinical data and the dedication of their teams. Similarly, Dr. Jula Inrig, Chief Medical Officer at Travere Therapeutics, emphasized that the decision affirms the clinical evidence from the PROTECT study and reinforces their commitment to improving outcomes for individuals with IgAN.

FILSPARI is the first Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved in Europe for the treatment of IgAN. It is a non-immunosuppressive therapy that offers an alternative treatment option for those affected by this chronic kidney condition. FILSPARI has already been available in Germany, Austria, and Switzerland under conditional marketing authorization since April 2024.

The standard MA is a significant milestone in providing broader access to this therapy, offering new hope for IgAN patients across Europe. The approval marks an important step in the ongoing effort to address the unmet needs in kidney disease treatment and patient care.