Vera Therapeutics Gets FDA Accelerated Approval for Trutakna in IgA Kidney Disease

By Doc Louallen

Vera Therapeutics said the U.S. Food and Drug Administration granted accelerated approval for Trutakna to reduce proteinuria, or protein in urine, for adults with primary IgA nephropathy who are at risk of disease worsening.

Trutakna is the first therapy that targets both B-cell activating factor and A PRoliferation-Inducing Ligand, the immunological drivers at the source of IgAN, the company said. The dose is 150 mg once weekly, self-injected at home with an autoinjector, it said.

The approval is based on an interim analysis from the ongoing Phase 3 Origin 3 study. Patients on Trutakna saw a 46% drop from baseline in proteinuria, and a statistically significant and clinically meaningful 42% reduction versus placebo at 36 weeks, Vera said. The company added that Trutakna was generally well tolerated, with the most common side effects being infections and injection-site reactions.

This accelerated approval is based on reduction of proteinuria, Vera said. It has not yet been shown whether Trutakna slows kidney function decline over the long term, it said.

IgA nephropathy is a serious, progressive kidney disease and a leading cause of chronic kidney disease and kidney failure worldwide. Vera said about 160,000 people in the U.S. are estimated to be affected.

Write to Doc Louallen at Doc.Louallen@wsj.com

(END) Dow Jones Newswires

July 07, 2026 13:51 ET (17:51 GMT)