The US Food and Drug Administration has granted accelerated approval to atacicept-vymj (Trutakna) for reducing proteinuria in adults with primary immunoglobulin A nephropathy who are at risk for disease progression, according to a press release from the agency.
Primary immunoglobulin A (IgA) nephropathy is a kidney disease in which an abnormal form of the IgA antibody accumulates in the kidneys, leading to inflammation and kidney damage. The condition can result in proteinuria and progressive loss of kidney function that may lead to kidney failure.
According to the US Food and Drug Administration (FDA), atacicept is the first approved therapy to target both B-cell activating factor and A Proliferation Inducing Ligand, proteins involved in the survival and maturation of certain immune cells.
The efficacy and safety of atacicept were evaluated in a randomized, double-blind, placebo-controlled clinical trial (NCT04716231) that enrolled adults with biopsy-confirmed primary IgA nephropathy. Patients were randomly assigned to receive atacicept 150 mg administered subcutaneously once weekly or placebo.
The primary endpoint evaluated the change from baseline in proteinuria, measured by the urine protein-to-creatinine ratio from a 24-hour urine collection, after 9 months of treatment in the first 203 patients who reached the month 9 assessment. According to the FDA, patients who received atacicept had a 46% reduction in proteinuria at 9 months compared with patients who received placebo.
The FDA stated that atacicept suppresses the immune system and may increase the risk of infections. Patients should be evaluated for active infections before treatment initiation and monitored for signs of infection during therapy. Administration of live vaccines is not recommended within 30 days prior to treatment initiation or during treatment. The most common adverse reactions reported were infections, including upper respiratory tract infection, and injection site reactions, including injection site erythema.
Accelerated approval was granted based on the reduction in proteinuria. According to the FDA, it has not been established whether atacicept slows long-term kidney function decline in patients with primary IgA nephropathy. As a condition of accelerated approval, the ongoing clinical trial must be completed to verify whether atacicept slows long-term kidney function decline. Continued approval may be contingent on verification of clinical benefit in the confirmatory trial.
The application also received Priority Review and Breakthrough Therapy designation. Vera Therapeutics, Inc., received the approval.
Source: US Food and Drug Administration
