UAE becomes first country to approve new kidney disease treatment

The UAE has become the first country in the world to approve a new use of a medicine designed to help protect kidney function in adults suffering from a progressive kidney disease.

The Emirates Drug Establishment (EDE) has granted conditional approval for Ultomiris (ravulizumab), developed by pharmaceutical company AstraZeneca. The treatment is intended for adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of their condition progressing.

The medicine is designed to reduce protein leakage into the urine, an important indicator of kidney damage and disease progression.

Announcing the decision on Tuesday, the EDE said the approval reflects the UAE's efforts to strengthen its position as a global healthcare and pharmaceutical leader.

What Is IgA Nephropathy?

IgA nephropathy is an immune-related kidney disease in which a protein called immunoglobulin A (IgA) builds up in the kidneys, causing inflammation and gradual damage.

Over time, this condition can affect the kidneys' ability to filter waste and excess fluids from the blood.

One of the key warning signs is the presence of excess protein in the urine, a condition known as proteinuria.

Healthy kidneys normally prevent important proteins from passing into urine. However, when kidney filters become damaged, protein can leak through.

High levels of protein in urine may indicate that the disease is progressing and kidney function could deteriorate. In some patients, the condition can eventually lead to kidney failure.

How Can Ultomiris Help Protect Kidney Function?

Ultomiris (ravulizumab) is an intravenous treatment designed to target a specific part of the immune system that can contribute to inflammation and kidney damage.

For eligible adults with primary IgA nephropathy, the treatment aims to reduce the amount of protein leaking into the urine.

Reducing proteinuria is an important treatment goal because it can help doctors monitor disease progression and assess the risk of further kidney damage.

However, the approval does not mean the medicine is suitable for everyone with kidney disease. A specialist must assess each patient's condition and determine whether the treatment is appropriate.

What Does the Conditional Approval Mean for Patients?

The EDE's conditional approval introduces another potential treatment option for adults with primary IgA nephropathy who are at risk of disease progression.

As the approval is conditional, it comes with regulatory requirements and may involve additional evidence collection and ongoing monitoring.

The decision also reflects the UAE's approach to providing access to new medical treatments while maintaining strict standards for safety, quality and effectiveness.

UAE Strengthens Its Healthcare and Pharmaceutical Sector

According to the Emirates Drug Establishment, the approval supports the country's ambition to become a global leader in healthcare innovation and pharmaceutical development.

It also aligns with the UAE's We the UAE 2031 vision, which focuses on encouraging innovation, research and development across key sectors.

Dr Ruqaya Al Bastaki, Acting Executive Director of the Medical Products Regulation Sector at the EDE, said the decision demonstrates the country's commitment to making advanced medicines available while ensuring compliance with scientific and international regulatory standards.

She added that the establishment aims to strengthen the pharmaceutical sector and respond to emerging medical developments through a robust regulatory framework.

AstraZeneca Welcomes the UAE's Regulatory Decision

Sameh El Fangary, Gulf Cluster President at AstraZeneca, described the conditional approval as an important development in expanding treatment options for patients with IgA nephropathy.

He said the company looks forward to continuing its collaboration with healthcare partners in the UAE to support access to the treatment for eligible patients.
The collaboration aims to improve treatment outcomes and strengthen the quality of patient care.

Early Diagnosis and Regular Monitoring Remain Important

Alongside the new treatment option, the Emirates Drug Establishment highlighted the importance of early diagnosis and regular monitoring for people living with kidney disease.

Patients with IgA nephropathy should undergo regular medical assessments, including:

Kidney function tests: To monitor how effectively the kidneys filter waste from the blood.

Urine protein tests: To measure protein leakage and identify possible disease progression.

Regular specialist consultations: To review treatment effectiveness and identify potential complications.

Following prescribed treatment: To manage the condition and reduce the risk of further kidney damage.

Early detection, appropriate treatment and regular medical follow-ups can help patients manage IgA nephropathy and monitor changes in kidney health.

The UAE's conditional approval of Ultomiris marks a new development in the country's pharmaceutical sector, offering a potential additional treatment option for eligible adults living with this progressive kidney condition.