VERA - Calliditas Therapeutics Scores Complete FDA Approval Broader Label For Lead Kidney Disease Drug | Benzinga
The FDA approved Calliditas Therapeutics AB's (NASDAQ: CALT) Tarpeyo (budesonide) delayed-release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
Tarpeyo was first approved in December 2021 under accelerated approval based on the surrogate marker of proteinuria.
Marking a significant milestone, Tarpeyo is now the first fully FDA-approved treatment for IgAN based on a measure of kidney function.
Tarpeyo (investigational name Nefecon) is the only FDA-approved IgAN treatment to reduce kidney function loss.