The European Medicines Agency’s (EMA) human medicine committee has recommended Travere Therapeutics and CSL Vifor’s Filspari (sparsentan) for approval as a treatment for adults with primary IgA nephropathy (IgAN), a rare form of kidney disease.

If approved, Filspari will be the first non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist for the treatment of IgAN in Europe.

Estimated to affect around 25 per million adults worldwide, IgAN is the most common type of primary glomerular disease worldwide and the current leading cause of kidney failure.

The condition occurs when the immunoglobulin A (IgA) protein becomes trapped in the very fine filters of the kidney, resulting in damage and scarring to the kidney.

The Committee for Medicinal Products for Human Use (CHMP) has recommended Filspari as treatment in adults with primary IgAN with a urine protein excretion above 1g/day.

The recommendation was based on results from the pivotal phase 3 PROTECT study, which evaluated the safety and efficacy of 400mg of Filspari compared to 300mg of Avapro (irbesartan) in 404 patients aged 18 years and older with IgAN and persistent proteinuria.

Previously published in The Lancet and the New England Journal of Medicine, results from the study showed that Filspari demonstrated long-term kidney function preservation over two years in patients with IgAN and a rapid and sustained reduction in proteinuria in comparison to Avapro.

In August 2022, both companies submitted a marketing authorisation application for conditional marketing authorisation to the EMA, which had previously granted orphan medicinal product designation to Filspari for the treatment of IgAN.

The treatment is currently on the market in the US and has been granted accelerated approval by the US Food and Drug Administration based on a reduction in proteinuria.

Eric Dube, president and chief executive officer, Travere Therapeutics, said: “The positive recommendation from the CHMP represents a significant advancement [towards] the delivery of new treatment options for people living with IgAN in Europe,… who currently have no approved non-immunosuppressive treatment options.”

Emmanuelle Lecomte Brisset, senior vice president and head of global regulatory affairs at CSL, said: “We look forward to the European Commission decision and to continuing to advance… [and] provide innovative treatments for patients with kidney disease.”

https://pmlive.com/pharma_news/chmp-recommends-travere-and-csl-vifors-filspari-to-treat-rare-kidney-disease-igan/