Sparsentan is a first-in-class, orally active, single molecule that functions as a high-affinity, dual-acting antagonist of both endothelin type A (ETA) and angiotensin II subtype 1 (AT1) receptors, which are associated with progression of kidney disease. Its development for IgA nephropathy and FSGS promises to halt that progression for many patients and fills a gap in the treatment armamentarium.
• Orphan drug designation: U.S. Food and Drug Administration (FDA)
• Orphan drug designation: European Commission (EC)
• Priority review of New Drug Application (NDA) accepted: U.S. FDA
• Conditional marketing authorization accepted: European Medicines Agency (EMA)
February 17, 2023
• PDUFA date
Expected approval for IgAN:
• 2023: the United States and the European Union
Patents estimated to expire beginning in 2030
How will sparsentan impact the market for IgA nephropathy and FSGS?
What gaps in treatment does sparsentan fill?
Both IgA nephropathy and FSGS are rare kidney disorders that can lead to end-stage renal disease requiring dialysis or a kidney transplant. IgA nephropathy generally progresses slowly, while FSGS can follow an aggressive clinical course. Treatment is primarily directed at managing symptoms. Corticosteroids or other immunosuppressive drugs are routinely combined with renin-angiotensin-aldosterone system inhibitors (RAASIs), but these are limited by serious side effects. Therefore, effective, safe, and well-tolerated drugs that protect kidney function or slow the progressive decline in glomerular filtration rate (GFR) are needed.
What hurdles might it need to overcome to reach blockbuster status?
Sparsentan will not be the first treatment specifically for IgA nephropathy after the launch of TARPEYO in early 2022. Other potential competitors in what could become a competitive market are currently in late-stage development.
Access global intelligence, advanced analytics and global experts from Clarivate.