The FDA has approved Trutakna (atacicept‑vimj) from US‑based Vera Therapeutics for the treatment of IgA nephropathy – a progressive autoimmune kidney disease that can lead to organ failure and potentially require dialysis.
According to the regulator, this is the first drug approved in the United States that simultaneously targets two immune system proteins (BAFF and APRIL), thereby reducing the production of pathogenic IgA antibodies. Previously, patients with this condition had no such treatment options. Trutakna is the sixth drug available for the indication.
Vera Therapeutics said physicians can already prescribe the drug, but patients will only be able to access it within 3‑4 weeks. The wholesale acquisition cost for four doses – a 28‑day supply – is $32,700, or roughly $425,000 annually. The company plans to target about 9,000 patients with rapidly progressing disease out of the 160,000 affected in the United States. The market potential is estimated at $20 billion.
The FDA granted accelerated approval based on data from the Origin 3 trial, which showed a 42% reduction in urine protein compared with placebo at 36 weeks (and a 46% reduction from baseline). However, this is an intermediate endpoint, and the trial is ongoing to assess the drug’s effect on kidney function over the longer term. Vera plans to submit these data in the third quarter of 2026 – ahead of the original 2027 schedule. If efficacy is confirmed, Trutakna could receive full approval.
Trutakna enters a competitive market already featuring Voyxact (Otsuka), Fabhalta (Novartis), Filspari (Travere Therapeutics) and Tarpeyo (Calliditas Therapeutics). In addition, in November the FDA will review Vertex Pharmaceuticals’ application for povetacicept – another dual BAFF/APRIL inhibitor, which in trials reduced urine protein by 49.8%.
Vera Therapeutics is also studying atacicept in other autoimmune kidney diseases, including membranous nephropathy and focal segmental glomerulosclerosis. In parallel, the company is developing a next‑generation drug, VT‑109, with potentially less frequent dosing – once a quarter or less. The company expects this to help cement its leadership in the category.
