AstraZeneca has secured accelerated approval from the US Food and Drug Administration (FDA) for its Ultomiris treatment for adults with immunoglobulin A nephropathy, a rare kidney disease.
The approval was granted under the FDA’s accelerated pathway, following late-stage trial results showing that the treatment reduced proteinuria, or excess protein in the urine, by 43.4 per cent compared with a placebo after 34 weeks.
The pharmaceutical company said the findings were based on an interim analysis of a late-stage trial.
The ongoing trial will continue for 106 weeks to assess whether Ultomiris slows the loss of kidney function, a result that would support traditional approval of the treatment.
AstraZeneca said more than 200,000 people in the United States have immunoglobulin A nephropathy.
The company added that about half of patients with elevated urine protein levels or reduced kidney function face a high risk of kidney failure within 10 years.
