UAE becomes first country to approve new kidney disease treatment
EDE grants conditional approval to drip-based treatment to reduce protein leakage in urine
Dubai: The UAE on Tuesday said it has become the first country in the world to approve a new use of a medicine aimed at helping protect the kidneys of adults suffering from a condition that can gradually damage kidney function. The treatment is designed to reduce the amount of protein leaking into the urine, an important warning sign of kidney damage and a key indicator of whether the disease is getting worse.
The Emirates Drug Establishment (EDE) has granted conditional approval for this new use of Ultomiris (ravulizumab), developed by pharmaceutical company AstraZeneca.
The drip-based treatment is intended for adults with primary immunoglobulin A nephropathy (IgAN), an immune-related kidney disease, who are at risk of their condition progressing.
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Announcing the decision on Tuesday, the EDE said the approval supports the UAE's ambition to strengthen its position as a global leader in healthcare and pharmaceuticals.
It is also in line with the country's 'We the UAE 2031' vision, which focuses on promoting innovation, research and development across key sectors, EDE said.
Understanding the condition
IgA nephropathy is a disease in which the body's immune system mistakenly causes a protein called immunoglobulin A (IgA) to build up in the kidneys. This leads to inflammation and, over time, can damage the kidneys and affect their ability to filter waste from the blood.
One of the signs of this damage is the presence of excess protein in the urine. Normally, healthy kidneys prevent important proteins from passing into urine. When the kidney filters become damaged, protein can leak through.
High levels of protein in urine can indicate that the disease is progressing and that kidney function may deteriorate over time. In some patients, the condition can eventually lead to kidney failure.
Reducing protein leakage is therefore an important goal of treatment, as it may help limit further kidney damage.
What does the approval mean for patients?
The approval provides another potential treatment option for adults with IgA nephropathy who are at risk of their kidney disease getting worse.
Ultomiris is designed to target a specific part of the body's immune system that can contribute to inflammation and kidney damage in people with this condition.
However, the approval does not mean the medicine is suitable for everyone with kidney disease. It is specifically intended for eligible adults with primary IgA nephropathy, and a specialist doctor must determine whether the treatment is appropriate.
The approval is conditional, meaning it comes with regulatory requirements and may involve further evidence and monitoring.
Supporting UAE's healthcare ambitions
Dr Ruqaya Al Bastaki, Acting Executive Director of the Medical Products Regulation Sector at the Emirates Drug Establishment, said the decision reflects the country's commitment to ensuring that new medicines meet strict standards of safety, quality and effectiveness.
She said the EDE's regulatory framework aims to balance access to the latest medical advances with thorough scientific assessment and compliance with international standards.
The approval also demonstrates the establishment's efforts to strengthen the pharmaceutical sector and respond to new scientific developments and emerging treatments, further supporting the UAE's position in global pharmaceutical regulation.
Sameh El Fangary, Gulf Cluster President at AstraZeneca, described the conditional approval as an important step towards expanding treatment options for patients.
He said the company looked forward to continuing its collaboration with partners in the UAE to support access to the medicine for eligible patients, with the aim of improving treatment outcomes and the quality of care.
Early diagnosis and regular monitoring
The Emirates Drug Establishment also stressed the importance of identifying kidney disease early and monitoring patients regularly.
This includes checking kidney function and measuring protein levels in urine to assess whether the condition is stable or getting worse.
Patients are also advised to follow the treatment plan prescribed by their specialist and attend regular medical appointments to help manage the disease and reduce the risk of complications.
