Travere’s Filspari US Approval Marks First For IgAN

The US accelerated approval of Travere Therapeutics, Inc.’s novel treatment for immunoglobulin A nephropathy (IgAN), Filspari, should position it for a sizeable unmet market as the first non-immunosuppressive treatment for the disease. The drug’s label is expected give it access to around a third of IgAN patients and it will be priced competitively with another recent market entrant, Calliditas Therapeutics AB’s steroid product, Tarpeyo (budesonide), upon its launch at the end of the month.

The US Food and Drug Administration granted accelerated approval to Filspari (sparsentan) specifically to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression (generally a urine...