Vera Therapeutics received accelerated approval from the Food and Drug Administration on Tuesday for Trutakna, a treatment for adults with IgA nephropathy, a chronic autoimmune kidney disease.
The company said no previously approved U.S. drug has simultaneously inhibited both BAFF and APRIL — immune proteins whose role in driving antibody production leads to kidney damage over time. IgA nephropathy affects approximately 160,000 patients in the U.S. and, without effective treatment, can lead to kidney failure requiring dialysis or a transplant.
Interim data from the still-running ORIGIN 3 Phase 3 trial underpinned the regulatory decision: after 36 weeks, urinary protein — a marker of kidney damage — had declined 46% from pre-treatment levels among Trutakna recipients, outpacing the placebo group by 42 percentage points. The most common adverse reactions were infections, reported in 32% of Trutakna patients versus 28% of placebo patients, and local administration reactions, reported in 30% of Trutakna patients versus 5% of placebo patients, the company said.
Because the approval is accelerated, it is based on proteinuria reduction as a surrogate marker rather than a confirmed long-term effect on kidney function. Results measuring the drug's longer-term impact on kidney function are anticipated sometime in 2026's third quarter, an earlier readout than the previously projected 2027 timeline, the company said.
Patients inject Trutakna themselves once weekly using an autoinjector. A 28-day supply carries a wholesale acquisition cost of $32,700 — equivalent to roughly $425,000 annually — figures cited by Chief Commercial Officer Matt Skelton, according to Reuters. Prescriptions became available at the moment of approval, though the company said that supply reaching patients through distribution networks would take another three to four weeks.
Vera stock rose 7.1% on Tuesday following the announcement.
"The approval of TRUTAKNA as the first and only BAFF and APRIL inhibitor for IgAN marks an important milestone," Vera Therapeutics founder and CEO Marshall Fordyce said in a statement.
IgAN is diagnosed most often in people between 30 and 40 years of age, and at least 50% of patients may progress to kidney failure or death within 10 to 20 years of diagnosis, the company said. Several other treatments already exist for IgAN, and Trutakna's dual-protein mechanism sets it apart from currently approved options. Competitor Vertex Pharmaceuticals $VRTX has a pipeline candidate with a comparable mechanism, and regulators are expected to decide on that drug before the end of this year, according to The Wall Street Journal.