The Emirates Drug Establishment (EDE) has granted conditional approval for a new indication of AstraZeneca‘s Ultomiris (ravulizumab) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. The approval expands the treatment options available for eligible patients in the UAE and supports efforts to improve access to innovative medicines.
Primary IgA nephropathy is an immune-mediated kidney disease caused by the accumulation of immune proteins in kidney tissue, resulting in inflammation and potentially progressive loss of kidney function. Elevated protein levels in urine, known as proteinuria, are an important indicator of disease progression.
Ruqaya Aqeel Al Bastaki, Acting Executive Director of the Medical Products Regulation Sector at EDE, said “The approval reflects the effectiveness of the Establishment’s regulatory framework, which is based on rigorous scientific assessment and a balance between keeping pace with pharmaceutical advances and meeting requirements for safety, quality and efficacy.”
According to EDE, the conditional approval reflects its commitment to strengthening pharmaceutical regulation through scientific assessment and international standards of quality, safety and efficacy. Ruqaya Aqeel Al Bastaki, Acting Executive Director of the Medical Products Regulation Sector at EDE, highlighted the importance of balancing pharmaceutical innovation with patient safety and timely access to emerging treatments.
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Sameh El Fangary, Gulf Cluster President at AstraZeneca, said “The conditional approval represents an important step towards expanding the treatment options available to eligible patients in the UAE.”
Ultomiris has been registered in the UAE since 2022 for several rare diseases. The latest approval aligns with the UAE’s We the UAE 2031 vision and its efforts to advance pharmaceutical innovation and healthcare development. EDE also emphasised the importance of early diagnosis, regular kidney function monitoring and adherence to specialist-prescribed treatment plans to help manage the condition and reduce complications.
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