The FDA has approved Vera Therapeutics' Trutakna, a self-injectable drug for IgA nephropathy (Berger's disease) — a potentially fatal kidney condition. It's the first treatment to target both BAFF and APRIL immune proteins, which drive the disease. Approval was based on a late-stage trial showing a 42% reduction in urinary protein levels versus placebo after 36 weeks.
The FDA has given the green light to Vera Therapeutics' Trutakna, a self-administered injectable drug for IgA nephropathy (Berger's disease) — a serious autoimmune kidney condition where abnormal protein buildup can eventually lead to organ failure. It's a notable first: Trutakna is the only approved therapy to simultaneously target BAFF and APRIL, two immune-system proteins that fuel the production of disease-causing antibodies in IgA nephropathy and other autoimmune disorders.
The accelerated approval was based on promising late-stage trial data, and the ongoing study is now expected to deliver kidney-function results (measured by eGFR) in Q3 2026 — ahead of the originally planned 2027 timeline. Vera's CEO noted the urgency, saying high-risk patients simply can't afford to wait years for answers.
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Why it matters: Trutakna enters a growing but competitive IgA nephropathy market alongside drugs from Otsuka, Novartis, Travere, and Calliditas. Its unique dual-target mechanism could offer a meaningful new option — especially for patients who can't tolerate high-dose steroids and are at risk of progressing to dialysis.
