UAE Expands Treatment Options for Immune-Mediated Kidney Disease

The Emirates Drug Establishment grants conditional approval for a new use of Ultomiris, bringing advanced therapeutic options to patients with primary IgA nephropathy.

The Emirates Drug Establishment has granted conditional approval for a new indication of AstraZeneca’s Ultomiris, expanding the treatment landscape for patients managing primary immunoglobulin A nephropathy. The medication, already registered in the UAE since 2022 for several rare diseases, now carries approval to reduce proteinuria in adults with IgAN who face the risk of disease progression.

Primary IgA nephropathy represents an immune-mediated kidney disease characterised by the deposition of immune proteins within kidney tissue, a process that can trigger inflammation and lead to a gradual decline in kidney function. Proteinuria, the presence of elevated protein levels in urine, serves as a significant marker of disease progression, making therapeutic options that address this symptom particularly valuable for patients and their physicians.

Ruqaya Aqeel Al Bastaki, Acting Executive Director of the Medical Products Regulation Sector at the Emirates Drug Establishment, emphasised that the approval reflects the rigour of the Establishment’s regulatory framework. The decision, she noted, represents a balance between advancing pharmaceutical science and maintaining exacting standards for safety, quality and efficacy. The approval underscores the EDE’s commitment to strengthening the pharmaceutical sector’s capacity to respond to emerging scientific developments and to reinforce the UAE’s standing in pharmaceutical regulation.

The conditional approval aligns with the strategic priorities outlined in the “We the UAE 2031” vision, which seeks to enhance competitiveness across vital sectors including healthcare and pharmaceuticals while fostering innovation, research and development. Sameh El Fangary, Gulf Cluster President at AstraZeneca, described the approval as an important step toward expanding treatment options for eligible patients throughout the UAE, with the company expressing its intention to continue collaborating with partners to support patient access and improve treatment outcomes.

The Emirates Drug Establishment has highlighted the significance of early diagnosis, regular monitoring of kidney function and protein levels in urine, and adherence to treatment plans prescribed by specialist physicians as essential elements in managing the condition and reducing the risk of complications.

What it means for Abu Dhabi

This approval strengthens Abu Dhabi’s position as a centre for advanced healthcare innovation, reflecting the emirate’s commitment to ensuring residents have access to cutting-edge therapeutic options. The decision demonstrates the effectiveness of the UAE’s pharmaceutical regulatory system in keeping pace with global medical advances while maintaining stringent safety standards.

For patients in Abu Dhabi living with primary IgA nephropathy, the availability of this treatment represents an expansion of clinical options that may help slow disease progression and improve quality of life. The approval also reinforces the emirate’s role in supporting pharmaceutical development and research, positioning Abu Dhabi as a destination where medical innovation flourishes within a framework of regulatory excellence.

Source: WAM