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Kidney Function Preserved in Autoimmune Disease Study
6 Jun
Summary
- Voyxact maintained kidney function in a 12-month study.
- The drug showed potential to slow kidney function loss.
- A rolling submission for FDA approval is underway.
Otsuka Pharmaceutical has reported encouraging outcomes from a late-stage study of its drug, Voyxact. The medication demonstrated its ability to preserve kidney function over a 12-month period for individuals battling a specific autoimmune disease affecting the kidneys. This condition, known as primary immunoglobulin A nephropathy (IgAN), can cause inflammation and eventual kidney failure.
The study, which included 320 participants, observed an increase in estimated glomerular filtration rate (eGFR) among those receiving Voyxact. This measure indicates improved kidney filtration of toxins, contrasting with a decline seen in patients on a placebo. These findings provide early evidence that Voyxact may help mitigate the progression of kidney function loss in IgAN patients.
Voyxact, a monoclonal antibody administered every four weeks, offers convenient at-home treatment options. Otsuka Pharmaceutical has initiated a rolling submission to the U.S. Food and Drug Administration, seeking traditional approval based on 24-month data from the ongoing trial. The company anticipates receiving this comprehensive data within the next two months.
