Sharjah: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. This makes the UAE the first country worldwide to approve Ultomiris for this specific indication.
According to Sharjah 24, Ultomiris has been registered in the UAE since 2022 for the treatment of several rare diseases. The recent approval aligns with the UAE's strategic priorities under the “We the UAE 2031” vision, which aims to boost the country's global competitiveness in healthcare and pharmaceuticals and to advance innovation, research, and development.
Primary IgA nephropathy is an immune-mediated kidney disease caused by the deposition of an immune protein in kidney tissue, leading to inflammation and a gradual decline in kidney function. Elevated protein levels in the urine are crucial indicators of disease progression, underscoring the need for treatments that reduce proteinuria and limit further deterioration.
Dr. Ruqaya Al Bastaki, Acting Executive Director of the Medical Products Regulation Sector at EDE, stated that the establishment's regulatory framework is based on rigorous scientific assessment and balances pharmaceutical advances with the highest standards of safety, quality, and efficacy. The approval reflects EDE's commitment to strengthening the pharmaceutical sector's readiness to respond to scientific developments and emerging treatments.
Sameh El Fangary, Gulf Cluster President at AstraZeneca, described the conditional approval as a significant step towards expanding treatment options for patients. He expressed optimism about continuing collaboration with UAE partners to support access to the treatment for eligible patients, improve treatment outcomes, and enhance the quality of care. EDE also highlighted the importance of early diagnosis, regular monitoring, and adherence to treatment plans to manage the condition and reduce complication risks.