Sparsentan (sparsentan) has been officially approved by the European Union for the treatment of adult patients with IgA nephropathy

Recently, CSL Vifor and Travere Therapeutics jointly announced that its jointly developed IgA new kidney disease treatment drug Sparsentan (Sparsentan) has officially received full marketing approval from the European Commission (EC). This approval means that the drug has been successfully converted from the previous "Conditional Marketing Authorization" (CMA) to a "Standard Marketing Authorization" (MA), which is suitable for the treatment of urinary protein excretion ≥1. 0g/days or urinary protein/creatinine ratio ≥0.75g/g Adult patients with primary IgA nephropathy. The approval applies to all EU member states as well as European Economic Area countries such as Iceland, Norway and Liechtenstein.

As early as2023, sparsentan has received accelerated approval from the FDA in the United States, and was approved in < span>Full marketing authorization will be obtained in 2024, and it is suitable for adult patients with IgA kidney disease who are at risk of disease progression to delay the deterioration of renal function. IgAnephropathy (IgAN) is an immune-mediated chronic kidney disease, and its cause is closely related to the abnormal deposition of IgA immunoglobulin in the glomerulus. Patients often present with symptoms such as proteinuria, edema, and hypertension. The main goal of clinical treatment is to slow down proteinuria and renal function decline. Currently, commonly used drugs include ACE inhibitors, ARB drugs and SGLT2 inhibitors.

Sparsentan is a once-daily oral dual-action drug that has both endothelin receptor and angiotensinII receptor antagonistic functions. It is designed to block two key pathological pathways in the progression of IgA nephropathy. It has significant advantages over traditional treatments as a non-immunosuppressive regimen, especially for patients who have failed to respond to existing standard treatments. The drug is currently on the market in Germany, Austria and Switzerland, and is the first non-immunosuppressive drug approved for IgAN treatment in Europe.

The approval was based on positive data from the pivotalPhase III clinical studyPROTECT. This study is currently one of the largest randomized, double-blind, head-to-head clinical trials in the field of IgAN, comparing the efficacy and safety of spasentan and the ARB drug irbesartan. A total of 40418 years old and aboveIgAN were included in the trial. Patients who have persistent proteinuria despite high-dose ACEI or ARB treatment. The results showed that at 36 weeks, the proteinuria level of patients using sparsentan was reduced by an average of 49.8%, while the irbesartan group was only reduced by 15.1%, a significant difference. Two-year follow-up data shows that in terms of renal function preservation, sparsentan performs better in the eGFR (glomerular filtration rate) decline rate index, which has statistical and clinical significance.

In terms of safety, sparsentan is well tolerated. The most common adverse reactions include dizziness and hypotension. Its overall safety is comparable to that of the comparator drug. The approval of the EU standard marketing authorization marks a new stage in the treatment of IgA kidney disease and provides patients with more targeted treatment options. In the future, as the drug is promoted in more markets around the world, it is expected to further improve the long-term prognosis of IgAN patients.

References:CSL Vifor and Travere Therapeutics announce standard EU approval for FILSPARI® in IgA Nephropathy