Explaining Sparsentan’s Full FDA Approval and Other IgA Nephropathy Therapeutic Developments

Sparsentan (Filspari) is now the second fully FDA-approved IgA nephropathy therapeutic for reducing the loss of kidney function, earning this indication less than a year after budesonide (Tarpeyo) delayed release capsules earned full approval for primary IgAN in December of 2023.

Jonathan Barratt, PhD, FRCP, Mayer Professor of Renal Medicine at the University of Leicester, explains the significance of this development, calling attention to sparsentan’s novel mechanism of action allowing for blockage of both the renin-angiotensin system and the endothelial system. In the phase 3 PROTECT trial, blocking both systems with sparsentan led to significant improvements in kidney function decline over 2 years compared to irbesartan, which only blocks the renin-angiotensin system.

“Having had no drugs approved for the past 50 years in IgA nephropathy, we now have 4 in the space of the last couple of years, which is fantastic,” Barratt said. “I would hope we're likely to have a couple more drugs approved each year for the next 2 or 3 years.”

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