UAE grants conditional approval for Ultomiris in treatment of kidney disease

DUBAI: 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. Ultomiris has been registered in the UAE since 2022 for the treatment of several rare diseases. The approval supports the UAE’s strategic priorities and the objectives of the “We the UAE 2031” vision to strengthen competitiveness in vital sectors, including healthcare and pharmaceuticals, and advance innovation, research and development. It also aligns with EDE’s efforts to develop an advanced and proactive pharmaceutical regulatory system based on efficiency, regulatory excellence and international standards of quality, safety and efficacy, while accelerating access to new treatments. Primary IgA nephropathy is an immune-mediated kidney disease caused by the deposition of immune proteins in kidney tissue, potentially leading to inflammation and a gradual decline in kidney function. Elevated levels of protein in the urine are an important indicator associated with disease progression, highlighting the importance of treatment options that can reduce proteinuria and help manage the condition. 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. She added that the decision reflects EDE’s efforts to strengthen the pharmaceutical sector’s readiness to respond to scientific developments and emerging treatments and reinforce the UAE’s position in pharmaceutical regulation. 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. He added that AstraZeneca looks forward to continuing its cooperation with partners in the country to support patient access to the treatment and improve treatment outcomes and quality of care. EDE stressed the importance of early diagnosis, regular monitoring of kidney function and protein levels in the urine, and adherence to treatment plans prescribed by specialist physicians to support disease management and reduce the risk of complications.