A Phase 3 Study with Atacicept in Subjects With IgA Nephropathy (ORIGIN 3)

https://clinicaltrials.gov/study/NCT04716231?id=NCT04716231&rank=1&utm_medium=email&utm_source=govdelivery&viewType=Card Notable Approval: FDA Approves New Treatment to Reduce Proteinuria in Adults with Primary Immunoglobulin A Nephropathy The U.S. Food and Drug Administration (FDA) has approved Trutakna (atacicept-vymj) to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression. Trutakna is injected subcutaneously (under the skin) once weekly. Condition IgA nephropathy is a serious kidney disease that occurs when an abnormal form of an immunoglobulin A (IgA) antibody builds up in the kidneys, causing kidney inflammation and damage. This kidney damage can cause protein to leak from the blood into the urine (proteinuria) and loss of kidney function over time that may progress to kidney failure. Data Supporting Trutakna Trutakna is the first FDA-approved medicine that targets both B cell activating factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which are involved in survival and maturation of certain immune cells. This in turn decreases production of the abnormal IgA antibody. The efficacy and safety of Trutakna were evaluated in a randomized, double-blind, placebo-controlled clinical trial (NCT04716231) 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 (urine protein-to-creatinine ratio sampled from a 24-hour urine collection) 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. Safety Information Trutakna suppresses the immune system and may increase the risk of infections. Patients should be assessed for active infections before starting Trutakna and monitored for signs of infection during treatment. Trutakna may interfere with the immune response to vaccines and increase the risk of infection from live vaccines. Administration of live vaccines is not recommended within 30 days prior to starting Trutakna or during treatment with Trutakna. The most common side effects of Trutakna are infections (including upper respiratory tract infection) and injection site reactions, including injection site erythema (redness of the skin). Designations Trutakna was granted accelerated approval based on the reduction in proteinuria. It has not been established whether Trutakna slows kidney function decline over the long-term in patients with IgA nephropathy. As a condition of the accelerated approval, the ongoing clinical trial must be completed to confirm that Trutakna slows kidney function decline over the long-term in patients with IgA nephropathy. Continued approval may be contingent upon verification of clinical benefit in this confirmatory trial. The approval was granted to Vera Therapeutics, Inc. Trutakna also received priority review and Breakthrough Therapy designation for this indication.