Astrazeneca's Ultomiris wins accelerated US approval.
Drugmaker Astrazeneca's rare‑disease unit Alexion said on Thursday that Ultomiris had won accelerated US approval as the first treatment aimed at reducing protein levels in the urine of adults with primary IgA nephropathy.
Source: Sharecast
Astrazeneca said the decision followed a priority review by the Food and Dug Administration and was based on interim Phase III data showing Ultomiris delivered a 43.4% reduction in proteinuria versus placebo at 34 weeks.
However, the regulator stressed that it has not yet been proven whether the drug slows long‑term kidney decline, with continued approval dependent on results from the ongoing I CAN trial, which will measure kidney‑function change at week 106.
Ultomiris, given by IV infusion every eight weeks after a loading dose, was being studied as a potential long‑term therapy for IgA nephropathy, a rare kidney condition that can lead to chronic disease and, in many cases, kidney failure.
Late‑breaking data from the I CAN trial will be presented at Kidney Week 2026, with Astrazeneca aiming to convert the accelerated approval into full approval once confirmatory results become available.
As of 1135 BST, Astrazeneca shares were down 0.30% at 12,576p.
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