Vera's Trutakna approved by FDA for adults with primary IgA nephropathy

The U.S. Food and Drug Administration has approved Trutakna to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression. Trutakna is injected subcutaneously once weekly. The efficacy and safety of Trutakna were evaluated in a randomized, double-blind, placebo-controlled clinical trial in adults with biopsy-confirmed IgA nephropathy. Patients were randomly assigned to either Trutakna 150 mg injected subcutaneously once weekly or placebo. The primary efficacy endpoint assessed the change from baseline in proteinuria after 9 months of treatment in the first 203 patients who had the opportunity to reach the month 9 visit. At 9 months, patients in the Trutakna group had an average 46% reduction in proteinuria as compared to an proteinuria in the placebo group. The FDA approval was granted to Vera Therapeutics. Reference Link