The US FDA has granted accelerated approval to atacicept (Trutakna) for reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. Atacicept is a B-lymphocyte stimulator (BLyS/BAFF)-specific inhibitor and APRIL blocker. By inhibiting BAFF- and APRIL-mediated signaling, it reduces the production of serum galactose-deficient IgA1 (Gd-IgA1), a key driver in the pathophysiology of IgAN.
Clinical evidence The approval is based on interim results from an ongoing clinical trial involving 203 adults with primary IgAN. At 36 weeks, patients treated with atacicept achieved a 42% reduction in the urine protein-to-creatinine ratio compared with those receiving placebo. Dosage and administration Available as a single-dose pre-filled autoinjector (150 mg) Once weekly subcutaneous injection Contraindications Serious hypersensitivity to any…
