The Food and Drug Administration (FDA) has granted Priority Review for the supplemental New Drug Application for Tarpeyo® (budesonide) seeking full approval in the treatment of immunoglobulin A (IgA) nephropathy.
Tarpeyo is currently indicated to reduce proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) of 1.5g/g or greater. This indication was granted accelerated approval based on a reduction in proteinuria, which required Calliditas Therapeutics to provide additional data establishing clinical benefit.
The sNDA includes the full dataset from the phase 3 NefIgArd trial (ClinicalTrials.gov Identifier: NCT03643965), which evaluated the efficacy and safety of Tarpeyo in adults with biopsy-proven IgA nephropathy, estimated glomerular filtration rate (eGFR) of at least 35mL/min/1.73m2, and proteinuria (defined as either 1g/day or greater, or UPCR 0.8g/g or greater) who were on a stable dose of maximally-tolerated renin-angiotensin system inhibitor therapy.
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Findings showed a statistically significant improvement in renal function (based on eGFR measure compared with baseline) with Tarpeyo compared with placebo (P <.0001) over the 2-year study period, which consisted of 9 months of treatment followed by 15 months of follow-up. Benefits were observed regardless of UPCR baseline. The difference between Tarpeyo and placebo in 2-year eGFR total slope was reported to be approximately 3mL/min per year.
“We take great pride in the strong clinical evidence we have gathered, which we believe demonstrates Tarpeyo’s durable and clinically meaningful impact on kidney function in the treatment of IgAN,” said Richard Phillipson, Chief Medical Officer at Calliditas. “The combination of the significant eGFR benefit and the reduction in proteinuria lasting for the entire 15-month follow-up period in the full results of our phase 3 study provide strong rationale for establishing Tarpeyo as the standard of care for IgAN patients.”
A regulatory decision is expected on December 20, 2023.
This article originally appeared on MPR