Sparsentan能有效治病吗？

Introduction: Sparsentan is an oral dual endothelin-angiotensin receptor antagonist for the treatment of immunoglobulin A (IgA) nephropathy and focal segmental glomerulosclerosis (FSGS). In February 2023, Sparsentan received accelerated approval in the United States for the reduction of proteinuria in adult patients with primary IgA nephropathy who are at risk for rapid disease progression.

Can the generic version of Sparsentan also effectively treat diseases?

The original drug was developed by Travere Therapeutics in the United States. There are also generic drugs on the market. The more common ones are the generic drugs produced by Lucius, and their efficacy is basically the same as the original drug. The generic version of Sparsentan is basically the same as the original drug in terms of its ingredients, mechanism of action, and efficacy. Moreover, one kilogram of Sparsentan has been approved for sale by relevant regulatory authorities, indicating that it is effective in treating IgA nephropathy, and its efficacy is basically equivalent to that of the original drug.

When patients choose to use generic drugs, they should ensure that the drugs are approved for marketing through formal channels to ensure the quality and efficacy of the drugs.

Efficacy of Sparsentan

In an international, randomized, double-blind, active-controlled study, the efficacy of Sparsentan was compared with that of irbesartan in adults (≥18 years) with biopsy-proven IgA nephropathy and proteinuria of 1.0 g/day or greater despite receiving at least 12 weeks of maximal renin-angiotensin system inhibitor therapy. Participants were randomly assigned to receive sparsentan 400 mg once daily or irbesartan 300 mg once daily. The primary efficacy endpoint was the change in urine protein-to-creatinine ratio from baseline to week 36 based on 24-hour urine samples, assessed using a mixed model for repeated measures.

404 participants were randomly assigned to receive sparsentan (n=202) or irbesartan (n=202). At week 36, the geometric least squares mean percentage change from baseline in the urine protein-to-creatinine ratio was significantly higher in the sparsentan group (-49.8%) than in the irbesartan group (-15.1%), resulting in a relative reduction of 41% between groups.

For adults with IgA nephropathy, once-daily treatment with sparsentan can significantly reduce proteinuria and is more effective than treatment with irbesartan. The safety profile of sparsentan is similar to that of irbesartan.

About IgA nephropathy (IgAN)

IgA nephropathy is a rare, progressive kidney disease characterized by the accumulation of immunoglobulin A (IgA), a protein that helps the body fight infections, in the kidneys. IgA deposition causes the kidneys' normal filtering mechanism to break down, leading to blood in the urine (hematuria), protein in the urine (albuminuria), and a gradual loss of kidney function. Other symptoms of IgAN may include swelling (edema) and high blood pressure.

IgAN is the most common primary glomerular disease in the world and the main cause of renal failure. It is estimated that there are as many as 250,000 IgAN patients in approved areas.