RARE Daily

CHMP Adopts Positive Opinion for Travere’s Sparsentan to Treat IgA Nephropathy

February 23, 2024

Rare Daily Staff

The European Medicines Agency’s Committee for Medicinal Product for Human Use has recommended approval of Travere Therapeutics’ and CSL Vifor’s sparsentan for the treatment of adults with primary IgA nephropathy.

IgA Nephropathy (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.

Sparsentan is an endothelin and angiotensin II receptor antagonist indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression.

The CHMP recommendation for approval is for adults with primary IgAN with a urine protein excretion >1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). The CHMP opinion provides the basis for the European Commission’s final decision regarding a conditional marketing approval 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.

“The positive recommendation from the CHMP represents a significant advancement toward the delivery of new treatment options for people living with IgAN in Europe, who face the risk of progression to kidney failure and who currently have no approved non-immunosuppressive treatment options,” said Eric Dube, president and CEO of Travere.

The positive CHMP opinion is based on results from the pivotal phase 3 PROTECT study of sparsentan in IgAN, 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 at least 50 percent of max label dose and maximally tolerated ACE or ARB therapy.

Treatment with sparsentan resulted in a rapid and sustained reduction in proteinuria and demonstrated the potential to preserve kidney function and significantly delay time to kidney failure compared to an active comparator, suggesting long-term benefits in IgAN.

In 2021, Travere Therapeutics granted CSL Vifor exclusive commercialization rights for sparsentan in Europe, Australia and New Zealand. Travere and CSL Vifor expect the European Commission’s decision in the second quarter of 2024.

Sparsentan is currently marketed in the U.S. and granted accelerated approval by the U.S. Food and Drug Administration under the brand name Filspari based on reduction in proteinuria.

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