FDA full approval of Tarpeyo (budesonide delayed release), the only FDA-approved treatment for IgA nephropathy to significantly reduce the loss of kidney function

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

"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.”

The approval is based on data from the Company’s Phase III NefIgArd clinical trial, a randomized, double-blind, multicenter, study that assessed the efficacy and safety of Tarpeyo dosed at 16 mg once daily versus placebo on a background of optimized RASi therapy in adult patients with primary IgAN.

Taerpeyo is available exclusively through Calliditas specialty pharmacy, Biologics by McKesson. To get started with Tarpeyo prescribers must fill out a Tarpeyo Touchpoints Enrollment Form, which serves as a prescription. This Enrollment Form will connect patients with all the benefits provided by Tarpeyo Touchpoints , including financial aid programs that can eliminate or reduce out-of-pocket costs, assistance from our team of care navigators, pharmacists, and nurse educators; and the convenience of at-home, next-day delivery. At Calliditas, we believe that the cost of treatment should never be a barrier to care. With Tarpeyo Touchpoints, 97% of patients taking Tarpeyo have paid less than $10 per prescription, and 88% have paid nothing at all.