European Commission grants conditional marketing authorization to Filspari
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Key takeaways:
- Filspari is intended for adults with primary IgA nephropathy who have a urine protein excretion of at least 1 g/day.
- The drug is expected to launch in the first European markets in the second half of 2024.
The European Commission has granted conditional marketing authorization to Filspari, Travere Therapeutics and CSL Vifor announced in a press release.
Filspari (sparsentan) is intended for adults with primary IgA nephropathy (IgAN) who have a urine protein excretion of at least 1 g/day or urine protein-to-creatinine ratio of at least 0.75 g/g.
The approval is an “important milestone for the IgAN community in Europe and underscores our promise to develop and deliver innovative medicines in our areas of focus where there is unmet need,” Emmanuelle Lecomte Brisset, senior vice president and head of global regulatory affairs at CSL Vifor, said in the release. “We look forward to working with our partners and EU member states to bring this innovative therapy to patients in Europe.”
The authorization is based on results from the phase 3 PROTECT study. After 36 weeks, patients receiving sparsentan achieved a mean reduction in proteinuria from baseline of 49.8% vs. 15.1% for patients treated with irbesartan, according to the release. The 2-year confirmatory results showed sparsentan achieved statistical significance for the eGFR chronic slope endpoint vs. irbesartan and clinically meaningful kidney function preservation.
Conditional marketing authorization is granted for all member states of the EU, as well as in Iceland, Liechtenstein and Norway. The drug is the first non-immunosuppressive therapy approved for the treatment of IgAN, according to the release.
Travere granted CSL Vifor exclusive commercialization rights for the treatment in Europe, Australia and New Zealand in 2021. CSL Vifor expects to launch the drug in the first European markets in the second half of 2024.
“This is a significant step forward for patients in Europe living with IgAN, a rare and serious condition, and a leading cause of end-stage renal disease,” Jürgen Floege, MD, senior professor of the nephrology division and clinical immunology at the University Hospital, RWTH Aachen, Germany, and steering committee member for the PROTECT study, said in the release. “The approval of this innovative treatment is based on data from the only head-to-head phase 3 clinical trial in IgAN. Adult patients with IgAN who are at high risk of progressing to kidney failure will now have access to a new therapy that significantly reduces proteinuria and slows the progression of kidney disease.”
Reference:
Travere Therapeutics and CSL Vifor announce European Commission approves Filspari (sparsentan) for the treatment of IgA nephropathy. https://ir.travere.com/news-releases/news-release-details/travere-therapeutics-and-csl-vifor-announce-european-commission. Published April 24, 2024. Accessed April 25, 2024.
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