Vifor Pharma AG Secures Standard EU Approval for FILSPARI® in IgA Nephropathy

ST. GALLEN, Switzerland and SAN DIEGO, April 29, 2025 — In a significant development for the pharmaceutical industry, CSL Vifor and Travere Therapeutics have announced the European Commission’s conversion of conditional approval into standard marketing authorization for FILSPARI® (sparsentan) for the treatment of IgA Nephropathy (IgAN). This decision follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) in February 2025, based on comprehensive data from the phase-III PROTECT study.

The approval marks a pivotal moment for Vifor Pharma AG, a leading healthcare company headquartered in Glattbrugg, Switzerland. Specializing in iron deficiency, nephrology, and cardio-renal therapies, Vifor Pharma AG has consistently demonstrated its commitment to advancing therapeutic solutions on a global scale. With a market capitalization of €10.8 billion and a price-to-earnings ratio of 73.78, the company is well-positioned to capitalize on this new market opportunity.

The European Commission’s decision underscores the robustness of the PROTECT study’s findings, which provided compelling evidence of FILSPARI®’s efficacy and safety profile in treating IgAN. This approval not only enhances Vifor Pharma AG’s portfolio but also strengthens its competitive edge in the nephrology sector.

Meanwhile, the pharmaceutical landscape for IgA Nephropathy is becoming increasingly competitive. The recent FDA approval of Novartis’ VANRAFIA (atrasentan) has disrupted the market, prompting other major players like Vertex Pharmaceuticals, Vera Therapeutics, and AstraZeneca to accelerate their efforts in bringing new candidates to the IgAN market. Despite VANRAFIA’s strong proteinuria reduction capabilities, it carries similar safety warnings, necessitating ongoing liver and pregnancy monitoring.

As Vifor Pharma AG navigates this dynamic environment, the standard EU approval for FILSPARI® positions the company as a key player in the IgAN treatment landscape. Investors and stakeholders can anticipate strategic initiatives aimed at maximizing the therapeutic’s potential and expanding its reach across Europe.

In conclusion, the standard EU approval for FILSPARI® represents a significant milestone for Vifor Pharma AG, reinforcing its role as an innovator in the healthcare sector. With a strong market presence and a focus on addressing unmet medical needs, the company is poised for continued growth and success in the evolving pharmaceutical industry.