• July 21, 2024

Calliditas IgAN treatment, Tarpeyo, given full FDA approval

IgAN or primary immunoglobulin A neuropathy is an autoimmune disease that occurs when clumps of antibodies are deposited in your kidneys, causing inflammation and kidney damage. 

Tarpeyo was first approved in December 2021 under accelerated approval, based on the surrogate marker of proteinuria. Marking a significant milestone, it is now the first fully FDA-approved treatment for IgAN based on a measure of kidney function.

Tarpeyo is now approved with a confirmed and statistically significant benefit over placebo in estimated glomerular filtration rate (eGFR) over the two-year period that consisted of 9 months of treatment with Tarpeyo plus optimized renin-angiotensin system inhibitor (RASi) or placebo and optimized RASi and 15 months of follow-up off study drug.

The treatment is a B-cell immunomodulator designed to target a source of the disease and reduce the production of pathogenic galactose-deficient IgA1 antibodies, which cause IgAN.

Proteinuria reduction

The company says significant proteinuria reduction was achieved with Tarpeyo plus RASi at 9 months was durable and maintained throughout the 15-month off-drug period.

The FDA approval is for adults with primary IgAN who are at risk of disease progression, irrespective of proteinuria levels.

“The evidence of sustained reductions in proteinuria and a clinically significant reduction in the loss of eGFR, which can help slow the progression towards dialysis or transplant care, highlights the potential of Tarpeyo as a disease-modifying agent in IgAN,” said Richard Lafayette, medical director, Stanford Healthcare.  

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