Vera Therapeutics Wins FDA Approval for TRUTAKNA in IgA Nephropathy, Sets Launch

Vera Therapeutics Wins FDA Approval for TRUTAKNA in IgA Nephropathy, Sets Launch

Vera Therapeutics won accelerated FDA approval for TRUTAKNA (atacicept-vymj) to treat adults with primary IgA nephropathy at risk of disease progression, making it the first and only BAFF and APRIL inhibitor for reducing proteinuria in this disease. Phase 3 ORIGIN 3 data supported the decision, showing a 46% reduction in proteinuria from baseline and a 42% reduction versus placebo, with the treatment generally well-tolerated and no serious or opportunistic infections reported. Vera is launching commercial sales with 82 reps, expects TRUTAKNA to be available in channel within three to four weeks, and set a list price of $32,700 per carton (about $425,000 annually) while it awaits confirmatory data for full approval later this year.

Vera Therapeutics NASDAQ: VERA said the U.S. Food and Drug Administration granted accelerated approval to TRUTAKNA, or atacicept-vymj, for adults with primary IgA nephropathy at risk for disease progression. The company said TRUTAKNA is the first and only BAFF and APRIL inhibitor indicated to reduce proteinuria in adult patients with primary IgA nephropathy, a kidney disease that Vera executives described as driven by B-cell activity. The approval is based on proteinuria reduction, with a confirmatory kidney function endpoint still pending.

Marshall Fordyce, Vera’s founder and chief executive officer, called the approval “a significant milestone” for patients, the nephrology community and the company. He said IgA nephropathy is fueled by BAFF and APRIL, which activate B cells and contribute to the formation of immune complexes ...