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Calliditas Therapeutics announces full FDA approval of TARPEYO®, the only FDA-approved treatment for IgA nephropathy to significantly reduce the loss of kidney function

发布时间: 2023-12-28 阅读:59次

December 20, 2023 -- Calliditas Therapeutics AB, today announced that the U.S. Food and Drug Administration (FDA) has approved 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 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 (p<0.0001) 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.

At 2 years, there was a 6.11 mL/min/1.73 m2 decline in eGFR in the TARPEYO group compared with a 12.0 mL/min/1.73 m2 decline in the placebo group (p<0.0001), representing 50% less deterioration of kidney function in TARPEYO-treated patients compared to placebo-treated patients over the 2-year period. Significant proteinuria reduction achieved with TARPEYO plus RASi at 9 months was durable and maintained throughout the 15-month off-drug period.

“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, MD, FACP, Stanford Healthcare.  “TARPEYO provides physicians and patients an effective treatment option to help improve disease outcomes.”

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