The UAE just conditionally approved a new use for Ultomiris for immune-mediated kidney disease, after the prescription was first registered in the UAE in 2022 for the treatment of several rare diseases.
The Emirates Drug Establishment (EDE) 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.
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.
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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.
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.
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.
Source: Khaleej Times