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.

About sparsentan

  1. Travere Therapeutics Inc
  2. Dual endothelin angiotensin receptor antagonist (DEARA)
  3. Daily oral administration to treat IgA nephropathy and FSGS
  4. IgA nephropathy: ~200,000–350,000 people with IgA nephropathy globally
  5. FSGS: Affects approximately seven in one million individuals

Why is it a drug to watch?

  1. Preclinical data have shown that blockades of both ETA and AT1 pathways can reduce proteinuria, protect podocytes and prevent glomerulosclerosis in rare chronic kidney diseases such as IgA neuropathy and FSGS.
  2. Data from the phase 3 PROTECT trial supported the submission to the FDA for IgA nephropathy. The study showed a greater than threefold reduction in proteinuria from baseline after 3 weeks compared with the active control irbesartan (angiotensin II receptor binder).
  3. The phase 3 DUPLEX trial for FSGS is ongoing. Interim data showed significantly more people in the sparsentan arm (42%) achieved FSGS partial remission endpoint (FPRE) than in the irbesartan comparator arm (26%).
  4. If approved for both indications, it could be the first treatment on the market to address both populations.
  5. In September 2021, Travere Therapeutics Inc and Vifor Pharma AG entered a collaboration and licensing agreement for the commercialization of sparsentan in Europe, Australia and New Zealand.

Review and approval status

IgA nephropathy

January 2021:
• Orphan drug designation: U.S. Food and Drug Administration (FDA)

February 2021:
• Orphan drug designation: European Commission (EC)

May 2022:
• Priority review of New Drug Application (NDA) accepted: U.S. FDA

August 2022:
• 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?

  1. The first commercially available treatment specifically for IgA nephropathy is TARPEYO™, which was approved by the U.S. FDA via the accelerated approval pathway and launched in Q1 2022.
  2. If trial data from sparsentan provide evidence that it protects kidney function, it could have a competitive advantage over TARPEYO, which is awaiting additional data to determine if it slows the decline of kidney function.
  3. Because of different mechanisms of action, it remains to be seen if sparsentan and TARPEYO will vie for the same IgA nephropathy market.

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.

expected sales in 2027
probability of success for sparsentan in the United States.

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