AstraZeneca's (NASDAQ: AZN) Alexion unit said the FDA has accepted and granted priority review for its supplemental biologics license application for Ultomiris (ravulizumab) to treat adults with immunoglobulin A nephropathy.

The FDA grants priority review to applications for medicines that could offer significant improvements over available treatment options through safety or efficacy improvements. The agency's action date is expected in the fourth quarter of 2026.

Immunoglobulin A nephropathy is a rare inflammatory kidney disease that can lead to chronic kidney disease and progress to end-stage kidney disease. More than 217,000 people are diagnosed with the condition in the U.S.

The application is based on results from an interim analysis of the Phase III I CAN trial. In the trial, Ultomiris demonstrated a 46.6% reduction in 24-hour urine protein creatinine ratio from baseline at week 34, compared to 5.6% in patients receiving placebo, resulting in a placebo-adjusted treatment effect of 43.4%.

The reduction in proteinuria was observed as early as week 10 with Ultomiris and sustained through 34 weeks. The trial's primary endpoint of change from baseline in estimated glomerular filtration rate will be measured at week 106.

The safety profile observed in the trial was consistent with the known profile of Ultomiris and was generally well tolerated, with no new safety concerns identified, according to the company statement.