FDA Approves Sparsentan, With Data Indicating Slowing of Kidney Function Decline in IgA Nephropathy

Full traditional approval follows accelerated approval of the medication last year.

The FDA has announced full approval for sparsentan (Filspari; Travere Therapeutics), an oral, once-daily, non-immunosuppressive medication which can significantly slow the decline of kidney function in adult patients with primary immunoglobulin A nephropathy (IgAN), according to a news release from Travere Therapeutics.¹

A detailed view of kidneys showing the effects of chronic kidney disease, including damaged nephrons

IgA nephropathy can lead to a slowing of kidney functions. © arti om | stock.adobe.com

Sparsentan’s approval is based on long-term confirmatory results from the PROTECT study, which demonstrated that the drug significantly slowed kidney function decline over a 2-year period compared with irbesartan (Avapro; Sanofi). The trial enrolled 404 patients, randomized to receive either sparsentan or irbesartan. There was a statistically significant treatment effect of 1.2 mL/min/1.73m²/year (p = .0168), indicating its effectiveness.¹

The medication was well-tolerated among the participants and featured a clearly defined safety profile that is consistent with other clinical trials that have occurred to date. Important for the consideration of the results, the PROTECT study was one of the largest interventional studies to date in IgAN, and the only phase 3 head-to-head trial for this indication.¹

“We know that most people living with IgAN are at risk of disease progression and are seeking a safe, effective and convenient treatment option that can help preserve their kidney function,” Eric Dube, PhD, president and chief executive officer of Travere Therapeutics, said in the news release.“Full approval now enables physicians to confidently prescribe sparsentan more broadly as a once-daily, oral, non-immunosuppressive treatment, that can provide superior preservation of kidney function and replace current standard of care.”¹

Sparsentan was previously granted an accelerated approval from the FDA in February 2023 based on preliminary, preclinical results of PROTECT. Investigators, in August 2021, reported that proteinuria was reduced by 49.8% at baseline with sparsentan, while the mean reduction with irbesartan-based treatment was just 15.1%.²

In a statement after its accelerated approval, Dube predicted that “sparsentan has the potential to ultimately become the new standard of care for IgANNow, following the publishing of 2-year confirmatory data, sparsentan has a clear path ahead to becoming an effective standard care option.²

About the Trial

Trial Name: A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy (PROTECT)

ClinicalTrials.gov: NCT03762850

Sponsor: Travere Therapeutics, Inc.

Estimated Completion Date: July 2026

IgAN, also known as Berger’s disease, is a progressive kidney disease that is characterized by the buildup of immunoglobulin A, which is a protein that helps the body fend off infections. Deposits of IgA lead to a destruction of the normal kidney filtering mechanisms, which can lead to hematuria or proteinuria, as well as a progressive loss of kidney function.¹

“As a physician who has dedicated my career to treating patients with glomerular diseases, I believe the full approval of FILSPARI for IgAN provides us with a critically important tool for patient management,” Brad Rovin, MD, steering committee member for the PROTECT study, said in the news release.“This approval should facilitate patient access to a medication that targets injury directly in the kidney, reduces proteinuria, even to the point of complete remission in some patients, and is more effective than current standard-of-care treatment in preserving kidney function over time.“¹

REFERENCES

1. Travere Therapeutics, Inc. Travere Therapeutics announces full FDA approval of FILSPARI (sparsentan), the only non-immunosuppressive treatment that significantly slows kidney function decline in IgA nephropathy. Yahoo!Finance. News Release. Released September 5, 2024. Accessed September 6, 2024. https://finance.yahoo.com/news/travere-therapeutics-announces-full-fda-213400876.html?guccounter=1&guce_referrer=aHR0cHM6Ly9zdGF0aWNzLnRlYW1zLmNkbi5vZmZpY2UubmV0Lw&guce_referrer_sig=AQAAAA0VYf4HDzKRybAEfunSJnhfn8pW-ONXCI2n9C_2pqJTMFFNd-LdsstIbz8KtX-zD_vLWrB_iGdXvlVcETFHtwssNM01UGjfzTs48z0OfpcViU8nTZSA4cl8c5-mv7n6lid2elc6jdK23SOa-DzxZf0OilBPZnBjexReh9GHDz0w

2. Hunter E. FDA grants accelerated approval to sparsentan for progressive form of kidney disease. Pharmacy Times. Published February 22, 2023. Accessed September 6, 2024. https://www.pharmacytimes.com/view/fda-grants-accelerated-approval-to-sparsentan-for-progressive-form-of-kidney-disease