← All approvals · Kidney, liver & lung · 2026
Trutakna (atacicept-vymj)
The FDA approved Trutakna (atacicept-vymj) on July 7, 2026 to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression.
- Brand name
- Trutakna
- Generic name
- atacicept-vymj
- FDA approval date
- July 7, 2026
- Approved use (FDA wording)
- To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression
- Company
- Vera Therapeutics Inc..
- Application
- BLA761486
- Dosage form / route
- INJECTABLE · SUBCUTANEOUS
- Boxed warning on label
- Not listed
- Category on this site
- Kidney, liver & lung
Indications and usage, from the FDA label
TRUTAKNA is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether TRUTAKNA slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial. TRUTAKNA is a B-lymphocyte stimulator (BLyS)-specific inhibitor and A Proliferation Inducing Ligand (APRIL) blocker indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at ri…