FDA Grants Vera Therapeutics Accelerated TRUTAKNA Approval After 46% Proteinuria Reduction
VERA•FDA granted accelerated approval to Vera Therapeutics' TRUTAKNA for adults with IgA nephropathy after ORIGIN 3 showed a 46% reduction in proteinuria from baseline and a 42% decrease versus placebo at 36 weeks. The 150 mg weekly self-administered dose targets BAFF and APRIL pathways and reaches about 160,000 patients.
1. FDA Approval and Trial Results
The FDA granted accelerated approval to TRUTAKNA for reducing proteinuria in adults with primary IgA nephropathy based on the ORIGIN 3 trial’s interim analysis showing a 46% reduction from baseline and a 42% decrease versus placebo at 36 weeks (p<0.0001). TRUTAKNA was generally well tolerated, with infections and local administration reactions as the most common adverse events.
2. Mechanism and Dosage
TRUTAKNA (atacicept-vymj) is the first therapy to inhibit both BAFF and APRIL cytokines, targeting B-cell immunological drivers in IgAN. Patients self-administer a 150 mg subcutaneous injection weekly via an autoinjector at home.
3. Market Impact and Patient Population
IgA nephropathy affects approximately 160,000 adults in the U.S., representing a significant addressable patient base for TRUTAKNA. This first-in-class approval positions Vera Therapeutics to generate initial commercial revenue and capture unmet needs in a serious kidney disease market.
4. Next Steps and Confirmatory Data
Continued approval depends on verification of clinical benefit in the ongoing ORIGIN 3 trial’s eGFR endpoint, with results expected in Q3 2026. Vera has scheduled an investor webcast to discuss the accelerated approval and future development plans.
