UAE conditionally approves new use of Ultomiris for kidney disease patients

The UAE has conditionally approved a new use of AstraZeneca’s Ultomiris to treat adults with primary immunoglobulin A nephropathy (IgAN), who are at risk of the disease progressing.

The Emirates Drug Establishment (EDE) said the treatment can be used to reduce proteinuria, or high levels of protein in the urine, which is an important indicator of the condition’s progression.

Primary IgA nephropathy is an immune-related disease caused by the build-up of immune proteins in kidney tissues. This can lead to inflammation and a gradual decline in kidney function.

Ultomiris, also known as ravulizumab, has been registered in the UAE since 2022 for the treatment of several rare diseases.

The conditional approval follows a scientific assessment of the treatment’s safety, quality and effectiveness, and is part of efforts to speed up access to new therapies in the UAE.

"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," said Ruqaya Aqeel Al Bastaki, Acting Executive Director of the Medical Products Regulation Sector at EDE.

The EDE also stressed the importance of early diagnosis, regular monitoring of kidney function and protein levels, and following treatment plans prescribed by specialist doctors.