CSL Vifor and Travere Therapeutics Announce European Commission approves FILSPARI® (sparsentan) for the treatment of IgA Nephropathy
First non-immunosuppressive therapy for the treatment of IgA Nephropathy (IgAN) approved in
Conditional marketing authorization is based on statistically significant and clinically meaningful results from the phase-III PROTECT trial
"This is a significant step forward for patients in
"The approval by the
"As the first and only non-immunosuppressive therapy approved for IgAN, we believe FILSPARI offers clinicians the potential for a new foundational treatment for this rare kidney disease, replacing RAAS inhibition," said
The
CSL Vifor expects to launch FILSPARI in the first European markets in the second half of 2024.
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
The parent company, CSL (ASX: CSL; USOTC: CSLLY), headquartered in Melbourne,
About
At
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.
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 the PROTECT study
The PROTECT Study is one of the largest interventional studies to date in IgA nephropathy (IgAN) and the only head-to-head trial in this rare kidney disease. It is a global, randomized, multicenter, double-blind, parallel-arm, active-controlled clinical trial evaluating the safety and efficacy of 400 mg of sparsentan, compared to 300 mg of irbesartan, in 404 patients ages 18 years and up with IgAN and persistent proteinuria despite receiving maximum tolerated dose and at least 50% of maximum labelled dose of ACE or ARB therapy. In August 2021, Travere announced the PROTECT Study met its primary endpoint at the pre-specified interim analysis . Based on the pre-specified, primary analyses set, after 36 weeks of treatment, patients receiving sparsentan achieved a mean reduction in proteinuria from baseline of 49.8%, compared to a mean reduction in proteinuria from baseline of 15.1% for irbesartan-treated patients (p<0.0001). The study's confirmatory secondary endpoint in the EU is eGFR chronic slope, measured from week 6 to week 110 of treatment, following the initial acute effect of randomized treatment. The confirmatory secondary endpoint in the U.S. is eGFR total slope from day 1 to week 110 of treatment. In September 2023, Travere announced topline two-year confirmatory secondary endpoint results from the PROTECT Study of sparsentan in IgAN. Sparsentan demonstrated long-term kidney function preservation and achieved a clinically meaningful difference in eGFR chronic and total slope versus irbesartan achieving statistical significance in eGFR chronic slope for purposes of regulatory review in the EU, and narrowly missing statistical significance in eGFR total slope. Patients who completed the PROTECT double-blind portion of the study on treatment were eligible to participate in the open-label extension of the trial. In PROTECT, the most common adverse reactions (≥ 5%) were peripheral edema, hypotension (including orthostatic hypotension), dizziness, hyperkalemia, and anemia.
About FILSPARI (sparsentan)
FILSPARI is a novel, 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). Pre-clinical data have shown that blockade of both endothelin type A and angiotensin II type 1 pathways in forms of rare chronic kidney disease, protects podocytes, prevents glomerulosclerosis and mesangial cell proliferation, and reduces proteinuria.
For more information please refer to the product overview on the
FILSPARI was developed by
CSL Vifor Media Contact |
|
Thomas Hutter |
|
+41 79 957 96 73 |
|
|
|
|
|
|
|
Investors: |
Media: |
888-969-7879 |
888-969-7879 |
View original content to download multimedia:https://www.prnewswire.com/news-releases/csl-vifor-and-travere-therapeutics-announce-european-commission-approves-filspari-sparsentan-for-the-treatment-of-iga-nephropathy-302125154.html
SOURCE