Travere Therapeutics Inc. plans to file for accelerated approval in the first half of next year, based on data from the pivotal phase III Protect study of sparsentan, a dual-acting antagonist of the endothelin type A (ETA) and angiotensin II type 1 receptors, for IgA nephropathy (IgAN).
Sweden’s Calliditas Therapeutics AB has licensed its rare kidney disease therapy to Stada Arzneimittel AG in Europe to help it navigate the complexity of the region’s market, ahead of a potential European and U.S. approval in the coming months.
With the table set for phase III data due next month from a trial testing Travere Therapeutics Inc.’s sparsentan against focal segmental glomerulosclerosis (FSGS), investor appetite grows ever sharper for prospects in kidney disease.
Calliditas Therapeutics AB, filled with confidence by positive top-line results from a phase III trial of its oral budesonide, Nefecon, in patients with primary immunoglobulin A nephropathy (IgAN), said it plans to seek accelerated approval for the drug from the FDA in the first quarter of 2021.
