Abu Dhabi:The Emirates Drug Establishment (EDE) has conditionally approved a new use for AstraZeneca's Ultomiris (ravulizumab) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression.

According to Wam, 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 goals and the 'We the UAE 2031' vision, aiming to enhance competitiveness in key sectors such as healthcare and pharmaceuticals, and to promote innovation, research, and development.

Primary IgA nephropathy is an immune-mediated kidney disease characterized by the deposition of immune proteins in kidney tissue, potentially causing inflammation and a gradual decline in kidney function. Elevated protein levels in urine are indicative of disease progression, making treatments that reduce proteinuria crucial for managing the condition.

Ruqaya Aqeel Al Bastaki, Acting Executive Director of the Medical Products Regulation Sector at EDE, emphasized that the approval demonstrates the effectiveness of EDE's regulatory framework, which balances scientific advancements and safety requirements. She noted that the decision strengthens the UAE's pharmaceutical sector's capacity to respond to scientific developments.

Sameh El Fangary, Gulf Cluster President at AstraZeneca, remarked that this conditional approval is a significant step towards expanding available treatment options for eligible patients in the UAE. He expressed AstraZeneca's commitment to collaborating with national partners to support patient access and enhance treatment outcomes.

EDE highlighted the importance of early diagnosis, regular monitoring of kidney function and protein levels, and adherence to treatment plans to effectively manage the disease and minimize complications.