UAE Gives Conditional Approval to AstraZeneca's Ultomiris for IgA Kidney Disease

The EDE said the UAE was the first country in the world to approve this new use of the drug. The US record suggests otherwise. HCPLive, a medical news outlet, reported that the US Food and Drug Administration (FDA) granted Ultomiris accelerated approval on October 21, 2026. That approval covers reducing protein in the urine of adults with primary IgAN who are at risk of disease progression, which appears to be the same use. The EDE announcement, as reported, did not mention the US decision.

The approval adds a treatment option for UAE patients with a disease that can lead to kidney failure. It is also part of the federal regulator's effort to approve new medicines early. The EDE said the decision supports the UAE's aim to be a global leader in healthcare and pharmaceuticals and fits the country's 'We the UAE 2031' vision.

IgAN is an immune disease. A protein called immunoglobulin A builds up in the kidneys, causing inflammation that can slowly damage their ability to filter waste from the blood. One warning sign is protein leaking into the urine, and the more protein leaks, the more likely the disease is to progress. Ultomiris, which is given by intravenous drip, is meant to reduce that leakage by acting on a specific part of the immune system that drives the inflammation.

The approval is conditional. The EDE said this means it comes with regulatory requirements and may require further evidence and monitoring. The regulator said the drug is not suitable for everyone with kidney disease: it is for eligible adults with primary IgAN, and a specialist must decide whether a patient should receive it.

Dr Ruqaya Al Bastaki, Acting Executive Director of the Medical Products Regulation Sector at the EDE, said the decision shows the country's commitment to making sure new medicines meet strict standards of safety, quality and effectiveness. Sameh El Fangary, Gulf Cluster President at AstraZeneca, called the approval an important step towards giving patients more treatment options. He said the company would work with UAE partners to help eligible patients get the medicine.

The data behind the approval are from an interim analysis of a trial still under way. The US approval relied on the Phase III I CAN trial, which randomly assigned 485 patients in 28 countries to receive either ravulizumab or a placebo every eight weeks. At week 34, the measure of protein in urine fell 46.6% in the ravulizumab group and 5.6% in the placebo group, an adjusted difference of 43.4%, according to HCPLive. The interim analysis did not report how kidney function changed, and that result will only come at the end of the 106-week treatment period.

The week-106 kidney-function data will show whether reducing protein leakage translates into slower kidney decline. That is the evidence that regulators who grant conditional or accelerated approvals usually expect to see before making them permanent.