The US Food and Drug Administration (FDA) has granted accelerated approval to Trutakna (atacicept) for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
IgAN is due to the accumulation of IgA antibodies in the kidneys. In the early stages, patients with IgAN have no symptoms. The first sign of this condition may be blood in the urine. End-stage kidney disease may develop if the disease is not treated properly. In most instances, the cause of this condition is unknown; however, certain disorders have been linked with IgAN, such as cirrhosis of the liver, celiac disease, and HIV infection. The condition can also often be triggered by a viral illness.
Atacicpet is a soluble recombinant fusion protein containing the human transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to and inhibits the cytokines BAFF and APRIL, thereby attenuating the autoimmune response by B-cells.
The approval is based on interim results from the ongoing phase 3 ORIGIN 3 (NCT04716231) global, multicenter, randomized, double-blind, placebo-controlled clinical trial of adults with IgAN. The primary efficacy endpoint of the prespecified 36-week interim analysis was the change in 24-hour urine-protein-to-creatinine-ratio (UPCR) compared to placebo in the first 203 participants who had received at least 1 dose of atacicpet or placebo.
Participants treated with atacicpet achieved a 46% reduction from baseline in UPCR, with a statistically significant and clinically meaningful 42% reduction compared to placebo at 36 weeks. Proteinuria efficacy was consistent across prespecified subgroups of age, sex, race, region, baseline proteinuria, baseline eGFR, and baseline SGLT2i use. Participants who received atacicpet also experienced a 68% reduction in galactose-deficient IgA1 (Gd-IgA1).
Additionally, safety was assessed in 428 patients who had received at least 1 dose of atacicpet or placebo. Atacicpet was generally well tolerated with the most common adverse events being infections and local administration reactions.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in the ongoing ORIGIN 3 trial, as measured by estimated glomerular filtration rate (eGFR), with final results anticipated in Q3 2026.
For more information, click here.
To learn more about IgAN and other rare kidney conditions, visit https://checkrare.com/diseases/kidney-and-urinary-diseases/