FDA Approves Vera’s IgAN Therapy

Rare Daily Staff

The U.S. Food and Drug Administration has granted accelerated approval to Vera Therapeutics’ Trutakna for the treatment of adults with primary IgA nephropathy who are at risk of disease progression, marking the first commercial product for the company.

The approval allows Trutakna to be used to reduce proteinuria (excess protein in the urine) in adults with IgAN. The therapy introduces a new mechanism that targets key immune drivers of the disease, though questions remain about its long-term impact on kidney function.

IgA nephropathy, also known as Berger’s disease, is a serious and progressive autoimmune kidney disorder with a high unmet medical need. The disease is driven by the production of abnormal immunoglobulin A (Gd-IgA1), which triggers the formation of autoantibodies. These combine into immune complexes that become lodged in the kidney’s filtering units (glomeruli), causing inflammation and progressive damage. Up to 50 percent of patients may eventually develop end-stage renal disease (ESRD), or kidney failure, significantly affecting quality of life.

Trutakna is a recombinant fusion protein designed to block two immune signaling molecules, BAFF and APRIL. These cytokines support B-cell survival and autoantibody production and are implicated in IgAN, lupus nephritis, and other autoimmune diseases. By inhibiting both pathways, Trutakna aims to reduce the production of harmful antibodies.

The therapy is administered as a once-weekly subcutaneous injection using an autoinjector, allowing patients to self-administer treatment at home. As with other immune-modulating therapies, it carries safety warnings, including risks of infection and potential interference with vaccine responses.

The FDA’s decision is based on a prespecified interim analysis of the ongoing Phase 3 ORIGIN 3 trial, a global, randomized, double-blind, placebo-controlled study in adults with IgAN. Among the first 203 participants, those treated with Trutakna experienced a 46 percent reduction from baseline in 24-hour urine protein-to-creatinine ratio (UPCR). This corresponded to a statistically significant 42 percent reduction in proteinuria compared with placebo at 36 weeks.

These benefits were consistent across subgroups defined by age, sex, race, geographic region, baseline proteinuria, kidney function (eGFR), and use of SGLT2 inhibitors. Patients receiving Trutakna also showed a 68 percent reduction in Gd-IgA1 levels, a secondary endpoint reported descriptively.

No serious or opportunistic infections or cases of hypogammaglobulinemia were reported during the 36-week treatment period. Most adverse events were mild to moderate and did not require discontinuation of therapy.

The trial remains ongoing to evaluate long-term effects on kidney function, as measured by eGFR. Top-line results are expected in the third quarter of 2026. Current treatment guidelines emphasize slowing eGFR decline to near-normal rates (less than 1 mL/min/year), with proteinuria reduction serving as an important surrogate marker.

At least half of patients with IgAN may progress to kidney failure or death within 10 to 20 years of diagnosis, underscoring the need for therapies that can alter the course of the disease.

Vera Therapeutics is also exploring Trutakna in other autoimmune conditions where dual inhibition of BAFF and APRIL may provide clinical benefit.

“The approval of Trutakna as the first and only BAFF and APRIL inhibitor for IgAN marks an important milestone, and we believe it has the potential to meaningfully transform the treatment landscape,” said Marshall Fordyce, founder and CEO of Vera Therapeutics. “We believe Trutakna offers a novel approach to addressing this serious disease and can help advance care for patients with significant unmet needs.”