The dual BAFF/APRIL inhibitor becomes the first therapy targeting both pathways to receive FDA approval for primary IgA nephropathy.
The FDA has granted accelerated approval to atacicept-vymj in adults with primary immunoglobulin A nephropathy (IgAN). The approval is based on findings from the prespecified 36-week interim analysis of the phase 3 ORIGIN 3 trial (NCT04716231), presented at ASN Kidney Week. Continued approval will be contingent on confirmation of clinical benefit in the ongoing phase 3 study.
Mechanism of action
Atacicept is a recombinant fusion protein that inhibits both B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL). By targeting both pathways, atacicept is designed to reduce the formation of pathogenic immune complexes that contribute to inflammation and kidney damage.
Clinical trial data
The accelerated approval was supported by interim findings from the phase 3 ORIGIN trial. In the study, once-weekly subcutaneous atacicept significantly reduced proteinuria compared with placebo after 36 weeks of treatment, with a statistically significant, clinically meaningful 42% reduction relative to placebo (p <0.0001). Patients receiving atacicept also experienced a 46% reduction in proteinuria from baseline.
The ORIGIN trial is continuing to evaluate estimated glomerular filtration rate (eGFR), with these data expected in the third quarter of 2026 to support an application for full approval.
Expanding the treatment landscape
IgA nephropathy is the most common form of primary glomerular disease and remains a leading cause of chronic kidney disease. The approval of atacicept introduces the first dual BAFF/APRIL-targeting therapy for IgAN, adding a novel approach to an increasingly diverse treatment landscape.
Atacicept is administered as a once-weekly subcutaneous injection using an at-home autoinjector, which could support treatment adherence and reduce the need for administration in healthcare settings.
This content has been developed independently by Touch Medical Media for touchIMMUNOLOGY. This article was created by the touchIMMUNOLOGY team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) No funding was received in the publication of this article.
Cite: FDA grants accelerated approval to atacicept for IgA nephropathy. touchIMMUNOLOGY. July 8 2026.
Editor: Victoria Smith, Senior Content Editor.
