CSL Vifor and Travere Therapeutics Announce Swissmedic approval of FILSPARI® (sparsentan) for the treatment of IgA Nephropathy
CSL Vifor and Travere Therapeutics announced that Swissmedic has granted temporary marketing authorization for FILSPARI (sparsentan) to treat adults with primary IgA nephropathy (IgAN) with specific urine protein levels. The approval is based on the phase-III PROTECT trial results. This follows full marketing approval by the FDA in September 2024 and conditional marketing authorization by the EMA in April 2024.
Emmanuelle Lecomte Brisset of CSL highlighted the high unmet medical need for targeted IgAN therapy. Eric Dube of Travere Therapeutics emphasized FILSPARI's benefits as a non-immunosuppressive, once-daily oral treatment that can provide superior results compared to maximally dosed irbesartan.
- Swissmedic granted temporary marketing authorization for FILSPARI
- FILSPARI received full FDA approval and conditional EMA authorization
- FILSPARI offers a non-immunosuppressive, once-daily oral treatment for IgAN
- Phase-III PROTECT trial showed statistically significant and clinically meaningful results
- None.
Insights
The Swissmedic approval of FILSPARI for IgA nephropathy (IgAN) is a significant development in the treatment landscape. This targeted therapy addresses a high unmet medical need, offering a non-immunosuppressive option for adult patients with substantial proteinuria.
Key points to consider:
- FILSPARI demonstrated superior results compared to maximally dosed irbesartan in the PROTECT trial
- It's a once-daily oral medication, which may improve patient adherence
- The approval is based on phase-III clinical data, indicating robust efficacy and safety profiles
- This follows approvals in the US and EU, suggesting a global recognition of the drug's potential
For investors, this approval expands CSL Vifor and Travere Therapeutics' market reach, potentially driving revenue growth in the nephrology space. The temporary authorization status indicates ongoing monitoring, which is common for novel therapies.
This regulatory approval is a positive catalyst for both CSL Vifor and Travere Therapeutics (NASDAQ: TVTX). Key financial implications include:
- Market expansion: Entry into the Swiss market adds to the revenue potential following US and EU approvals
- First-mover advantage: As a targeted therapy for IgAN, FILSPARI may capture significant market share
- Partnership synergy: The collaboration between CSL Vifor and Travere leverages complementary strengths in development and commercialization
- Revenue diversification: For CSL (CSLLY), this adds to their portfolio in rare diseases, potentially offsetting risks in other segments
Investors should monitor uptake rates, pricing strategies and reimbursement decisions in Switzerland. The temporary authorization may impact initial sales velocity, but positive real-world data could lead to full approval and broader adoption.
Temporary marketing authorization is based on statistically significant and clinically meaningful results from the phase-III PROTECT trial
ST. GALLEN, Switzerland and SAN DIEGO, Oct. 17, 2024 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that Swissmedic has granted temporary marketing authorization for FILSPARI for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g).
"Swissmedic approval further demonstrates our promise to deliver transformational medicines for patients with serious diseases in our areas of focus," said Emmanuelle Lecomte Brisset, Senior Vice President and Head of Global Regulatory Affairs at CSL. "There is a high unmet medical need for a targeted therapy to treat IgAN and we look forward to providing access to this innovative treatment option for the Swiss IgAN community as fast as possible. Thank you to all of the patients who participated in the clinical trials, as well as our partners at Travere, for their dedication to deliver this important regulatory approval in
"FILSPARI targets damage directly in the kidney and offers patients a convenient, once daily, oral, non-immunosuppressive treatment that can provide superior results compared to maximally dosed irbesartan, supporting replacing their RASi," said Eric Dube, Ph.D., President and Chief Executive Officer of Travere Therapeutics. "Together with our partner, CSL Vifor, we look forward to people living with IgAN in Switzerland gaining access to this important medicine."
Swissmedic approval was supported by results from the pivotal phase-III PROTECT study of FILSPARI in IgAN and follows full marketing approval by the
About CSL Vifor
CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care).
The parent company, CSL (ASX: CSL; USOTC: CSLLY), headquartered in Melbourne,
About Travere Therapeutics
At Travere Therapeutics, we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow. For more information, visit travere.com.
About IgA Nephropathy (IgAN)
IgAN, also called Berger's disease, is a rare progressive kidney disease characterized by the buildup of immunoglobulin A (IgA), a protein that helps the body fight infections, in the kidneys. The deposits of IgA cause a breakdown of the normal filtering mechanisms in the kidney, leading to blood in the urine (hematuria), protein in the urine (proteinuria) and a progressive loss of kidney function. Other symptoms of IgAN may include swelling (edema) and high blood pressure.
While rare, IgAN is the most common type of primary glomerular disease worldwide and a leading cause of kidney failure. IgAN is estimated to affect up to 250,000 people in the licensed territories (
About FILSPARI (sparsentan)
FILSPARI is an innovative, non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist with high selectivity for the endothelin A receptor (ETAR) and the angiotensin II subtype 1 receptor (AT1R). For more information, please refer to the product overview on the Swissmedic website.
FILSPARI was developed by Travere Therapeutics and has been granted Orphan Drug Designation for the treatment of IgAN in
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SOURCE Vifor International AG (CSL Vifor)
FAQ
What is FILSPARI and what has Swissmedic approved it for?
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