The U.S. Food and Drug Administration (FDA) granted accelerated approval to atacicept (Trutakna) to reduce proteinuria in adults with primary IgA nephropathy who are at risk for disease progression. This approval was supported by data from the ORIGIN 3 study.

Atacicept functions by targeting B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL). The drug is administered as a once-weekly self-administered injection. The placebo-controlled phase III study demonstrated that atacicept led to a 42% reduction in proteinuria at week 36, and participants treated with atacicept experienced a 68% reduction in galactose-deficient IgA1, which was a secondary endpoint.

IgA nephropathy is the most common primary glomerulopathy, and it is diagnosed in an estimated 2.5 per 100,000 adults globally each year. The condition is typically diagnosed in young adulthood. Patients with IgA nephropathy develop kidney damage due to an abnormal accumulation of IgA antibodies, which then damages the glomeruli, leading to inflammation, proteinuria, and the potential for kidney failure. Approximately half of patients diagnosed with IgA nephropathy progress to kidney failure or death within 10 to 20 years.

Richard Lafayette, an investigator at Stanford University Medical Center, said, "Trutakna offers patients and their nephrologists an exciting new treatment advancement that inhibits both BAFF and APRIL, the two key cytokines that act on B cells, which are at the source of IgA nephropathy pathophysiology." He added, "I frequently hear from IgA nephropathy patients who are uncertain about what this disease may mean for their future, reflecting the historic high risk of poor outcomes with standard therapies."

As a condition of accelerated approval, data from the ongoing ORIGIN 3 trial must confirm that atacicept slows the decline of kidney function over the long term. Vera Therapeutics anticipates presenting results from the ORIGIN 3 trial later this year. The label for atacicept includes warnings concerning immunosuppression and an elevated risk of infections. The drug is contraindicated for patients with a history of serious hypersensitivity to atacicept or its components.

During the study, 32% of participants reported infections as an adverse event, with upper respiratory tract infection being the most common, occurring in 12% of participants. Local administration reactions were experienced by 30% of participants, with injection site reactions at 19% and injection site erythema at 6% being the most frequent.