The US Food and Drug Administration has approved California-headquartered Vera Therapeutics’ drug to treat patients with a potentially life-threatening kidney disease, reports Reuters.
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 build-up 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.
Vera said that while the drug was launched immediately after its approval and physicians “can start writing prescriptions right now”, patients will get it only “when it’s available in the channels within three to four weeks”.
Trutakna’s wholesale acquisition cost for four doses or a 28-day supply is $32 700, or $425 000 per year.
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.
Musician Ben Lager (65), who is enrolled in Vera Therapeutics’ trial, told Reuters 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’s Fabhalta, Travere Therapeutics’ Filspari and Calliditas Therapeutics’ Tarpeyo are already available.
Reuters article – US FDA approves Vera’s kidney disease drug (Open access)
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