FDA Clears Calliditas’ Tarpeyo for Reducing Harmful Urine Protein

Calliditas Therapeutics’ Tarpeyo (budesonide) has won FDA accelerated approval for reducing a harmful urine protein in adults with a rare kidney disease, primary immunoglobulin A (IgA) nephropathy.

Tarpeyo, an oral delayed-release formulation of the corticosteroid budesonide, is meant to lessen the risk of rapid disease progression and may slow the decline of kidney function. However, the therapy must still prove its clinical benefit in a confirmatory trial.

The FDA’s approval was supported by positive data from a 200-participant phase 3 study showing Tarpeyo reduced urine protein-to-creation ratio (UPCR) nine months after baseline vs. placebo. Patients receiving Tarpeyo saw an average UPCR reduction of 34 percent compared with a UPCR reduction of 5 percent in the placebo arm.

IgA nephropathy results from excessive IgA antibody deposit buildup in kidneys, causing inflammation that can damage kidney tissue, which can then make the kidneys leak blood and protein in urine. Complications from the disease include high blood pressure and chronic kidney disease, causing patients to eventually require dialysis or kidney transplantation.