The FDA has granted accelerated approval to Trutakna (atacicept-vymj) for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression.
The therapy, developed by Vera Therapeutics, is administered as a once-weekly subcutaneous injection and is designed to target both B cell activating factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), pathways involved in immune cell function and production of abnormal IgA antibodies.
Approval was based on data from a randomized, double-blind, placebo-controlled trial in patients with biopsy-confirmed IgAN. The primary endpoint evaluated changes in proteinuria after nine months of treatment. Patients receiving Trutakna achieved a 46% average reduction in proteinuria, compared with a 7% reduction in the placebo group.
IgA nephropathy is a chronic kidney disease characterized by deposition of abnormal IgA antibodies in the kidneys, leading to inflammation, proteinuria, and progressive loss of kidney function. The condition can ultimately result in kidney failure.
The FDA noted that the approval is contingent on confirmation of long-term clinical benefit. An ongoing study is expected to evaluate whether treatment with Trutakna slows decline in kidney function over time.
The therapy carries safety considerations related to immune suppression, including increased risk of infections. Patients should be screened for active infections prior to treatment and monitored during therapy. Use of live vaccines is not recommended during treatment.
Trutakna received Breakthrough Therapy designation and priority review for this indication.
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