US FDA approves Otsuka’s drug for a type of kidney disease
The U.S. Food and Drug Administration has approved Otsuka’s injectable drug to treat patients with a potentially life-threatening kidney disease, the health regulator’s website showed on Tuesday.
The drug, branded as Voyxact, was approved to reduce proteinuria in patients with primary immunoglobulin A nephropathy, which causes inflammation in the kidneys and can eventually lead to the organ’s failure.
In a late-stage study, Otsuka’s therapy cut levels of protein in the urine of patients, or proteinuria, by 51.2% after nine months of treatment.
The company hopes this improvement will also result in improved kidney function over time, John Kraus, chief medical officer at Otsuka told Reuters ahead of the approval.
Otsuka is continuing the late-stage trial to study the change in kidney function over 24 months as measured by estimated glomerular filtration rate (eGFR), which indicates the kidneys’ ability to filter toxins. The study is expected to be completed in early 2026.
