FDA grants accelerated approval for Tarpeyo to reduce proteinuria in IgA nephropathy.

This indication is approved under accelerated approval. It has not been established whether Tarpeyo slows kidney function decline in patients with IgAN. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial. This approval marks the successful transition for Calliditas to a commercial-stage biopharmaceutical company.

Tarpeyo is approved under accelerated approval based on achieving its primary endpoint of reduction in proteinuria in Part A of the NeflgArd pivotal Phase III study, an ongoing, randomized, double-blind, placebo-controlled, multicenter study conducted to evaluate the efficacy and safety of Tarpeyo 16 mg once daily vs placebo in adult patients with primary IgAN. The effect of Tarpeyo was assessed in patients with biopsy-proven IgAN, eGFR greater than 35 mL/min/1.73 m2, and proteinuria (defined as either greater than 1 g/day or UPCR greater than 0.8 g/g) who were on a stable dose of maximally-tolerated RAS inhibitor therapy.

Patients taking Tarpeyo (n=97) showed a statistically significant 34% reduction in proteinuria from baseline vs 5% with RASi alone (n=102) at 9 months. The treatment effects for the primary endpoint of UPCR at 9 months were consistent across key subgroups, including key demographic and baseline disease characteristics.

Richard Lafayette M.D., Professor of Medicine at Stanford University and the Director of the Stanford Glomerular Disease Center commented, “IgAN is a tough diagnosis for many patients, and it can progressively lead to the need for dialysis and/or kidney transplantation. The FDA approval of Tarpeyo now offers disease-specific treatment for patients with this complicated disease.”