Data comp: two IgA nephropathy therapies aiming for full approval
Two drugs received accelerated approval for IgA nephropathy: one has met its confirmatory endpoint, the other is moving ahead despite miss
Despite missing the confirmatory endpoint designed to support conversion of Filspari’s accelerated approval to full approval in the U.S., Travere believes the totality of the data is sufficient to submit the package to FDA in 1H24.
The company may be confident, but shares of Travere Therapeutics Inc. (NASDAQ:TVTX) fell 41% to $7.64 Thursday after it said Filspari sparsentan missed the confirmatory secondary endpoint in the Phase III PROTECT study, which compared the small molecule dual angiotensin and endothelin receptor antagonist with irbesartan to treat IgA nephropathy. ...