With the regulator’s traditional green light in IgA nephropathy, Filspari is up against Novartis’ Fabhalta—which won accelerated approval last month—and Calliditas’ Tarpeyo, which was approved in December 2023.
Tag Archive for: Filspari
Vifor Pharma and partner Travere Therapeutics on Friday won an endorsement for approval from the European Union’s drug regulator for their drug Filspari, part of an industry race to treat a rare, serious kidney condition known as IgAN.
Following two late-stage failures, Travere Therapeutics has unveiled the results of two Phase III studies, attempting to regain Filspari’s footing in IgA nephropathy and focal segmental glomerulosclerosis.
Topline data from the Phase III APPLAUSE-IgAN study showed that Novartis’ investigational complement inhibitor iptacopan met its pre-specified interim analysis primary endpoint, the company announced Monday.
Travere Therapeutics said on Friday the U.S. health regulator has granted accelerated approval to its drug to treat a type of chronic kidney disease, IgAN, in adults with a high risk of advancing to kidney failure.