The regulatory decision stems from interim data in the Phase 3 Origin 3 study, which demonstrated a 46% reduction in proteinuria from baseline. At the 36-week mark, patients receiving the weekly 150 mg autoinjector dose showed a 42% improvement compared to those on a placebo. While the drug is generally well tolerated, common side effects include localized injection-site reactions and various infections.

Trutakna represents a shift in approach by targeting both B-cell activating factor and A PRoliferation-Inducing Ligand. Because the approval is contingent on the reduction of protein in the urine, long-term evidence confirming that the drug successfully slows the decline of overall kidney function remains pending. Approximately 160,000 people in the United States suffer from this progressive condition, which frequently serves as a precursor to chronic kidney failure.