April 21 (Reuters) – AstraZeneca said on Tuesday its rare blood disorder drug Ultomiris has met the main goal of a late-stage trial, showing a reduction in protein found in the urine of patients with a rare kidney disease called IgA nephropathy (IgAN).
In an interim analysis, the drug showed statistically significant results at week 34 in adults at risk of their disease progression, the company said, adding that protein reduction was seen as early as week 10.
IgAN is a rare, inflammatory kidney disease in which abnormal proteins build up in the kidneys, triggering inflammation that impairs their ability to filter blood. It can lead to chronic kidney disease and progress to end-stage kidney disease if left untreated.
AstraZeneca said it plans to seek accelerated approval for the indication in key markets while continuing the trial to assess changes in kidney function at week 106, the study’s other primary endpoint.
Ultomiris, chemically known as ravulizumab, has already been approved in the United States, the EU and Japan for treating certain rare blood disorders and neurological conditions.
The drug’s safety profile was consistent with known risks and no new safety concerns were identified, the company said.
(Reporting by Yamini Kalia in Bengaluru; Editing by Janane Venkatraman and Sherry Jacob-Phillips)
Comments