Calliditas Therapeutics Submits Supplemental New Drug Application to U.S. Food and Drug Administration for Full Approval of TARPEYO®
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced the submission of a supplemental New Drug Application (“sNDA”) to the U.S. 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.
