Travere Therapeutics

Stories

Roche's sefaxersen meets phase 3 goal, joining IgAN market battle with Novartis

Competitor; markets Filspari for IgAN

Roche's experimental IgA nephropathy drug sefaxersen met its phase 3 primary endpoint on September 23, cutting proteinuria versus placebo at 37 weeks in the IMAgINATION study. The result, from a prespecified interim look, was strong enough that Roche is taking it to health authorities and planning a medical meeting presentation.

Updated Sep 23

First FSGS drug hits FDA delay after 8-year clinical journey

Rule Changes

Awaiting FDA decision on sparsentan for FSGS

No FDA-approved treatment for focal segmental glomerulosclerosis (FSGS) has ever existed. For the 40,000 Americans with this rare kidney disease—which drives half to kidney failure within a decade—the only options have been off-label immunosuppressants with mixed results.

Updated May 21