|
AstraZeneca PLC on Monday said the US Food & Drug Administration has accepted and granted priority review to a supplemental biologics licence application for Ultomiris as a treatment for adults with immunoglobulin A nephropathy. The Cambridge, England-based pharmaceuticals company said the application is based on pre-specified interim analysis of the phase III I CAN trial, in which Ultomiris achieved a 43.4% placebo-adjusted reduction in proteinuria at 34 weeks. The application was submitted by Alexion, the division of AstraZeneca focused on rare diseases. It was established back in 2021 following AstraZeneca’s acquisition of Alexion Pharmaceuticals Inc. AstraZeneca explained that immunoglobulin A nephropathy is a rare, inflammatory disease of the kidneys, that can lead to chronic kidney disease and advance to end-stage kidney disease. More than 217,000 people in the US are diagnosed with immunoglobulin A nephropathy, it noted. If approved, Ultomiris could become the first C5 complement inhibitor approved for the rare kidney disease, AstraZeneca said, adding that a decision by the FDA is expected during the fourth quarter of this year. The company said the safety profile is consistent with the medicine’s known profile, with no new safety concerns identified. Shares in AstraZeneca were up 0.5% at 13,528.00 pence in early trading on Monday in London. ‘Despite available treatments, people living with IgAN often progress to end-stage kidney disease, underscoring the urgent need for new disease-modifying approaches,’ said Alexion Chief Executive Marc Dunoyer. ‘Building on our pioneering leadership in complement science, this priority review reflects the strength of the interim analysis data from the I CAN trial and the potential of Ultomiris as the first C5 complement inhibitor to address terminal complement-driven inflammation in IgAN.’ Copyright 2026 Alliance News Ltd. All Rights Reserved.
|
