USFDA Approves Vera Therapeutics' Trutakna for Rare Kidney Disease IgA Nephropathy
New Delhi: The U.S. Food and Drug Administration said on Tuesday it had approved Vera Therapeutics' drug to treat patients with a potentially life-threatening kidney disease.
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.
Vera said that while the drug was launched immediately following its approval and physicians "can start writing prescriptions right now," patients will get it "when it's available in the channels in 3-4 weeks."
Chief Commercial Officer Matt Skelton said 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.
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 (4578.T), opens new tab Voyxact, Novartis' Fabhalta, Travere Therapeutics' Filspari and Calliditas Therapeutics' Tarpeyo are already available.
