MedCity News September 6, 2024
The FDA decision for Travere Therapeutics’ Filspari also expands its addressable patient population. The full approval comes nearly a year after the Travere drug narrowly missed the main goal of its confirmatory study.
A Travere Therapeutics drug for a rare disease that can progress to kidney failure has converted its status to full FDA approval, strengthening the product’s case to compete against two other therapies that received affirmative regulatory decisions in the past year, one of them a Novartis drug recently awarded accelerated approval.
The Travere drug, Filspari, treats immunoglobulin A nephropathy (IgAN), a disease in which a patient’s immune system produces excessive amounts of antibodies that damage the kidney. Filspari’s accelerated FDA approval last year relied on data showing...
Today's Sponsors
Today's Sponsor