SAN DIEGO - The European Commission has granted conditional marketing authorization for FILSPARI (sparsentan), a treatment for adults with primary IgA nephropathy (IgAN), announced Travere Therapeutics, Inc. (NASDAQ: TVTX) in partnership with CSL (OTC:CSLLY) Vifor. This authorization makes FILSPARI the first non-immunosuppressive therapy approved for IgAN in the European Union, Iceland, Liechtenstein, and Norway.
The decision, based on the Phase 3 PROTECT Study, shows that FILSPARI significantly reduces proteinuria and slows the progression of kidney disease in patients with IgAN. The study reported a 49.8% mean reduction in proteinuria from baseline for patients treated with FILSPARI, compared to a 15.1% reduction for those treated with the control drug irbesartan.
Experts see this approval as a significant advancement for patients with IgAN, which can lead to end-stage renal disease. The therapy is expected to launch in the first European markets in the second half of 2024.
IgAN, also known as Berger’s disease, is characterized by the buildup of immunoglobulin A in the kidneys, causing damage and potential kidney failure. The condition is the most common type of primary glomerulonephritis worldwide.
The PROTECT Study, the basis for the European Commission's authorization, was a global, multicenter trial comparing the efficacy and safety of sparsentan against irbesartan. The study's two-year results demonstrated that FILSPARI preserved kidney function more effectively than the control drug.
Travere Therapeutics and CSL Vifor are working to ensure access to FILSPARI for patients across Europe. The companies have emphasized their commitment to addressing unmet medical needs in the rare disease community.
This news article is based on a press release statement from Travere Therapeutics.
InvestingPro Insights
As Travere Therapeutics (NASDAQ: TVTX) heralds the approval of its novel treatment for IgA nephropathy, FILSPARI, investors are closely watching the company's financial health and market potential. According to InvestingPro data, Travere Therapeutics currently holds a market capitalization of $436.86 million.
Despite a challenging financial performance with a negative gross profit margin of -76.57% over the last twelve months as of Q1 2023, the company has seen substantial revenue growth of 32.69% during the same period.
One of the InvestingPro Tips highlights that Travere Therapeutics has more cash than debt on its balance sheet, which could provide some financial flexibility as they roll out FILSPARI in European markets. Moreover, the stock's Relative Strength Index (RSI) suggests that it is in oversold territory, indicating potential for a rebound.
Investors should note that analysts have recently revised their earnings upwards for the upcoming period, reflecting optimism about the company's future performance. Still, it is important to recognize that analysts do not anticipate the company will be profitable this year, and the stock has fared poorly over the last month with a price total return of -27.16%.
For those considering investing in Travere Therapeutics, InvestingPro offers additional insights and tips, including 10 more tips for a comprehensive analysis of the company's prospects. Use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription to access these valuable insights.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.