CSL Vifor and Travere Therapeutics have secured the European Commission (EC) approval for Filspari to treat adults with primary IgA nephropathy, with urine protein excretion of 1g/day or more.
Filspari, developed by Travere Therapeutics, is a non-immunosuppressive therapy classified as a dual endothelin angiotensin receptor antagonist.
It is highly selective for the endothelin A receptor and the angiotensin II subtype 1 receptor.
CSL Vifor holds exclusive rights for Filspari in Europe, Australia, and New Zealand.
The EC approval transitions Filspari’s status from conditional authorisation to standard.
It follows a recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use in February 2025.
The approval marks a significant advancement in the treatment options available for patients with IgA nephropathy in these regions.
Filspari is the only dual endothelin angiotensin receptor antagonist approved for IgA nephropathy treatment in Europe.
CSL Vifor global medical affairs head Vinicius Gomes De Lima said: “The decision by the European Commission is an important advancement for people living with IgAN in the EU.
“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 EC approval is based on comprehensive clinical data, including the Phase 3 PROTECT study in 404 patients, aged 18 years and above, with IgA nephropathy.
The Phase 3 study met its primary endpoint at the pre-specified interim analysis with statistical significance.
It showed that Filspari significantly slowed kidney function decline compared to irbesartan.
The regulatory approval applies to all European Union (EU) member states, along with Iceland, Liechtenstein, and Norway.
Filspari has been granted Orphan Drug Designation for the treatment of IgA nephropathy in the UK, Europe, and the US.
It is currently available in the US and initial European markets, including Germany, Austria, and Switzerland, following its conditional marketing authorisation in April 2024.
Travere Therapeutics chief medical officer Jula Inrig said: “The European Commission’s standard approval of FILSPARI is a meaningful step forward for people living with IgA nephropathy across Europe.
“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.”
