Calliditas Therapeutics AB (Calliditas) announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) seeking full approval of Tarpeyo (budesonide) delayed release capsules for the entire study population from the phase 3 NeflgArd study.
Tarpeyo is currently approved under accelerated approval to reduce proteinuria in adults with primary IgA nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) =1.5g/g.
The sNDA submission is based on the full data set from the phase 3 NefIgArd clinical trial, a randomized, double-blind, multicenter study which assessed the efficacy and safety of Tarpeyo (developed under the project name Nefecon) dosed at 16 mg once daily versus placebo on a background of optimized RASi therapy in adult patients with primary IgAN. The trial met its primary endpoint, with Tarpeyo demonstrating a highly statistically significant benefit over placebo (p value < 0.0001) in estimated glomerular filtration rate (eGFR) over the two-year period of 9-months of treatment with Tarpeyo or placebo and 15-months of follow-up off drug.
"The eGFR treatment benefit observed across the entire study population, irrespective of UPCR levels, provides further evidence that targeting IgAN at its source can offer patients a treatment that holds the promise of being disease modifying. We are pleased to be able to provide the FDA with the full results of our phase 3 study, and we look forward to interactions with the FDA regarding full approval of Tarpeyo,
