Tarpeyo Approved to Reduce Loss of Kidney Function in IgA Nephropathy

The Food and Drug Administration (FDA) has granted full approval to Tarpeyo^® (budesonide) to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

Tarpeyo was previously granted accelerated approval based on a reduction in proteinuria from the randomized, double-blind, multicenter, phase 3 NeflgArd trial (ClinicalTrials.gov Identifier: NCT03643965). The conversion to regular approval was based on data from an additional 165 patients with biopsy-proven IgAN, estimated glomerular filtration rate (eGFR) of at least 35mL/min/1.73m², and proteinuria (defined as either ≥1g/day or urine protein to creatinine ratio [UPCR] ≥0.8g/g) who were on a stable dose of maximally-tolerated renin-angiotensin system (RAS) inhibitor therapy.

Study participants were randomly assigned 1:1 to receive Tarpeyo 16mg once daily or placebo for 9 months, followed by a 2-week taper of either Tarpeyo 8mg once daily or placebo. Patients were then followed off-treatment for 15 months. The primary endpoint for Part B of the study (final analysis) was a time-weighted average of the log ratio of eGFR at each time point over 2 years relative to baseline. 

In the final analysis of 364 patients, treatment with Tarpeyo met the Part B primary endpoint. At 2 years, there was a 6.11mL/min/1.73m² decline in eGFR in the Tarpeyo arm and a 12.0mL/min/1.73m² decline in the placebo arm (difference of 5.9mL/min/1.73m² [95% CI, 3.3-8.5mL/min/1.73m²]; P <.0001). The favorable effect of Tarpeyo on eGFR was observed by the third month and did not appear to increase in magnitude over 2 years. 

Additionally, the percentage change in UPCR observed at 2 years was found to be consistent with the results seen in the interim analysis at 9 months. The interim analysis showed treatment with Tarpeyo reduced UPCR by 31% compared with placebo (95% CI, 16-42; P =.0001). 

“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 and investigator on the NefIgard trial.  “Tarpeyo provides physicians and patients an effective treatment option to help improve disease outcomes.”

Tarpeyo is supplied as a 4mg delayed-release capsule. It is available exclusively through a specialty pharmacy. Prescribers can enroll their patients using the Tarpeyo Touchpoints^® Enrollment Form.