EU approval granted for rare kidney disease treatment
Ella Day | April 29, 2025 | News story | Market Access, Research and Development, Sales and Marketing | CSL Vifor, EU, Nephrology, Travere Therapeutics, kidney disease, nephrology
The EU has granted marketing authorisation (MA) for Filspari – CSL Vifor and Travere Therapeutics’ therapy for primary IgA nephropathy (IgAN), a rare kidney disease – advancing the ability to administer the therapy to patients globally.
Filspari is a dual endothelin angiotensin receptor antagonist (DEARA), a non-immunosuppressive therapy for the treatment of IgAN. Travere, which specialises in rare disease treatments, developed the drug, and CSL Vifor, a company that focuses on nephrology therapies, has commercial rights over it.
Travere’s PROTECT clinical study of the drug had positive results as it demonstrated that Filspari significantly slowed kidney function decline over two years compared to irbesartan, a conventional treatment drug for IgAN.
Using these optimistic results, the Committee for Medicinal Products for Human Use (CHMP) recommended that Filspari be converted from a conditional marketing approval (CMA) to an MA. Positive recommendation was received in February earlier this year.
Despite being a rare kidney disease, IgAN – or Berger’s disease – is a leading cause of kidney failure globally, demonstrating the need for a more effective treatment. It is characterised by a buildup of immunoglobulin A (IgA), a protein that helps fight kidney infection, leading to blood and protein in urine and a progressive loss of kidney function.
“The EU’s standard approval of Filspari is a meaningful step forward for people living with IgAN,” said Jula Inrig, chief medical officer at Travere.
Vinicius Gomes De Lima, head of global medical affairs at CSL Vifor, commented: “We look forward to continuing working (…) to ensure access to Filspari across Europe.”
Ella Day
29/04/25
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