The approval is based on clinically meaningful and statistically significant improvements in proteinuria in comparison to an active comparator in the ongoing phase 3 PROTECT study
FILSPARI is intended to reduce proteinuria in adults with primary IgAN. (Credit: Travere Therapeutics, Inc.)
Travere Therapeutics has secured accelerated approval from the US Food and Drug Administration (FDA) for FILSPARI (sparsentan) for the reduction of proteinuria in adults with primary IgA nephropathy (IgAN).
The approval is for patients facing the risk of rapid disease progression, generally a urine protein-to-creatinine ratio greater than or equal to 1.5 g/g.
FILSPARI is a daily-once oral non-immunosuppressive medication that selectively targets two critical pathways in the disease progression of IgAN.
Its approval is based on clinically meaningful and statistically significant improvements in proteinuria in comparison to an active comparator irbesartan in the phase 3 PROTECT study.
The late-stage study is comparing 400mg of FILSPARI with 300mg of irbesartan in 404 patients, aged 18 years and over who have IgAN and persistent proteinuria.
After 36 weeks of treatment, patients administered with FILSPARI achieved a mean reduction in proteinuria from baseline of 49.8%, compared to a 15.1% reduction in the irbesartan arm.
The ongoing PROTECT study is a global, randomised, multicentre, double-blind, parallel-arm, active-controlled clinical trial. Its topline data from the two-year confirmatory endpoints are anticipated in Q4 2023, based on which the FDA will decide on the traditional approval of FILSPARI.
Travere Therapeutics president and CEO Eric Dube said: “The accelerated approval of FILSPARI is a significant milestone on our path to advancing a transformative treatment for the IgA nephropathy community.
“As a first-of-its-kind, non-immunosuppressive therapy, we believe FILSPARI has the potential to ultimately become the new standard of care for IgA nephropathy and offer hope to those living with this condition who until now have had few treatment options.”
The company has a license agreement in place with Ligand Pharmaceuticals for sparsentan.
Under the terms of the licensing deal, Ligand Pharmaceuticals is eligible to earn a net $15.3m milestone payment on the FDA approval. Ligand Pharmaceuticals will also qualify for other prospective milestone payments, and net royalties of 9% on future global net product sales of FILSPARI.
Ligand Pharmaceuticals CEO Todd Davis said: “We are delighted to see the approval of sparsentan, now FILSPARI, which represents a significant step forward in improving the lives of patients living with IgA nephropathy.
“Our partnership with Travere has been a remarkable journey, and we are proud to have played a part in bringing this innovative treatment to market.”