FDA’s Filspari approval opens Travere’s two-year window

FDA’s accelerated approval of Filspari gives Travere two years to establish the small molecule as the new standard of care for IgA nephropathy, before the next of many new modalities reaches the market. However, concerns that a risk of liver toxicity and restricted label could hamper uptake sent Travere’s stock down after the approval was announced. 

Filspari sparsentan is FDA’s second accelerated approval in the rare disease indication. The first, in 2021, was for corticosteroid Tarpeyo budesonide from Calliditas Therapeutics AB (SSE:CALTX; NASDAQ:CALT). Tarpeyo had net sales of SEK123.4 million ($12 million) in 3Q22...