The US FDA gave accelerated approval to sparsentan as the first non-immunosuppressive therapy labeled for IgA nephropathy. Conventional approval awaits clinical outcomes data.
Delayed-release budesonide reduced proteinuria in patients with primary IgA nephropathy in a pivotal trial, which led to an FDA accelerated approval in December 2021 for the orphan drug.
Oral budesonide delayed-release (Tarpeyo) became the first agent to receive FDA approval for reducing proteinuria in patients with primary IgA nephropathy and at risk for rapid progression.