• 27 Feb 2024
• Admin
• News Article

EMA Recommends Marketing Authorization for Sparsentan

EMA committee recommends conditional marketing authorization for CSL Vifor & Travere Therapeutics’ sparsentan to treat IgA nephropathy 

Overview

CSL Vifor,` a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology, and Travere Therapeutics, Inc., a biopharmaceutical company, announced that the European Medicines Agency's (EMA) CHMP has recommended approval of sparsentan for the treatment of adults with primary IgAN with a urine protein excretion >1.0 g/day (or urine protein-to-creatinine ratio =0.75 g/g).

First Option

IgAN is a rare kidney disorder and a leading cause of kidney failure. The CHMP opinion provides the basis for the European Commission's final decision regarding CMA for sparsentan. If approved in Europe, sparsentan will be the first non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist for the treatment of IgAN.

Statement From CSL

"The positive CHMP opinion for sparsentan is one step closer to bringing this treatment option to patients in Europe with IgAN, a rare and serious condition that can cause kidney disease,"said Emmanuelle Lecomte Brisset, senior vice president and head of global regulatory affairs at CSL. "We look forward to the European Commission decision and to continuing to advance CSL's promise to provide innovative treatments for patients with kidney disease."

Futuristic Positive Response from Studies

• "The positive recommendation from the CHMP represents a significant advancement towards the delivery of new treatment options for people living with IgAN, who face the risk of progression to kidney failure and who currently have no approved non-immunosuppressive treatment options. 
• The PROTECT Study is the only head-to-head study in IgAN against a maximally labelled dose of irbesartan, a current standard of care. 
• The study demonstrated treatment with sparsentan resulted in a rapid and sustained reduction in proteinuria and has the potential to preserve kidney function and significantly delay time to kidney failure compared to an active comparator, suggesting long-term benefits in IgAN,"" said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics.
• "Together with CSL Vifor, we look forward to the European Commission's decision in the second quarter of 2024."

Trial Behind Positive Response

The positive CHMP opinion is based on results from the pivotal phase-III PROTECT study of sparsentan in IgAN, In August 2022, CSL Vifor and Travere Therapeutics announced they had submitted a Marketing Authorization Application (MAA) for CMA to the EMA. 

• The European Commission previously granted Orphan Medicinal Product Designation to sparsentan for the treatment of IgAN.
• If approved, sparsentan would receive a CMA in all member states of the European Union, as well as in Iceland, Liechtenstein and Norway. 
• Sparsentan is currently marketed in the US and granted accelerated approval by the US Food and Drug Administration under the brand name Filspari based on reduction in proteinuria.

In 2021, Travere Therapeutics granted CSL Vifor exclusive commercialization rights for sparsentan in Europe, Australia and New Zealand.

About 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.

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.

About Sparsentan

• Sparsentan 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. 
• Sparsentan is currently available in the US and was granted accelerated approval by the US Food and Drug Administration in February 2023 under the brand name Filspari based on reduction in proteinuria. 
• In September 2023, Travere Therapeutics reported two-year confirmatory results from the phase 3 PROTECT Study of FILSPARI in IgAN.

About CSL Vifor

CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology.

Travere Therapeutics

Travere Therapeutics is 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.