By Siddhi Mahatole
July 7 (Reuters) – The U.S. Food and Drug Administration has approved Vera Therapeutics’ drug to treat patients with a potentially life-threatening kidney disease, the regulator said on Tuesday, sending its shares up 6.8% in afternoon trading.
The drug Trutakna is a self-administered injectable treatment approved for patients with immunoglobulin A nephropathy, also known as Berger’s disease, which causes abnormal protein buildup in the kidneys and could eventually lead to the organ’s failure.
Trutakna is the first and only drug that targets the immune-system proteins BAFF and APRIL, which are involved in the production of disease-causing antibodies in IgA nephropathy and other autoimmune disorders.
The accelerated approval is based on a late-stage study in which the drug reduced protein levels in the urine by 42% compared with placebo after 36 weeks of treatment. Patients receiving the drug saw a 46% decline from baseline.
The trial is continuing to evaluate its effect on kidney function, measured by estimated glomerular filtration rate (eGFR), with data now expected in the third quarter of 2026, ahead of the previous 2027 timeline.
Vera CEO Marshall Fordyce told Reuters the company has pushed for an earlier assessment of kidney-function data, arguing that high-risk patients cannot afford to wait years while their disease progresses.
Ben Lager, a 65-year-old Denver musician enrolled in Vera Therapeutics’ trial, told Reuters that he lived with IgA nephropathy for decades before being diagnosed through a kidney biopsy in 2020.
Unwilling to take high-dose steroids due to potential side effects, and with no non-steroidal alternatives yet approved, he joined the trial in 2021. He said blood and protein in his urine disappeared within weeks of starting treatment and his energy levels improved.
Lager, currently in an ongoing trial, said the drug “saved my life and my kidneys from dialysis.”
Trutakna is entering a competitive market for IgA nephropathy, where Otsuka’s Voyxact, Novartis’ Fabhalta, Travere Therapeutics’ Filspari and Calliditas Therapeutics’ Tarpeyo are already available.
(Reporting by Siddhi Mahatole and Puyaan Singh in Bengaluru; Editing by Vijay Kishore)
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