UAE becomes first country to conditionally approve AstraZeneca drug for Berger’s disease

The UAE has conditionally approved a new use for AstraZeneca’s drug Ultomiris, expanding treatment options for adults with Berger’s disease, a chronic kidney condition that can worsen over time.

The Emirates Drug Establishment said the drug will be approved for adults at risk of disease progression, making the country the first to approve the medicine for this purpose.

Berger’s disease, also known as Immunoglobulin A nephropathy (IgAN), is an immune-mediated kidney disease that occurs when a protein produced by the immune system accumulates in the kidneys, causing inflammation and damage. This causes inflammation and can gradually damage their ability to filter waste from the blood.

Ultomiris, also known as ravulizumab, works by blocking part of the immune system that drives inflammation in the kidneys. This helps limit the damaging immune response triggered by Berger’s disease. It treats an effect of the disease rather than removing the protein buildup that causes it.

Ultomiris has been registered in the UAE since 2022 for several rare diseases. The latest decision expands how the existing medicine can be used.

“The approval reflects the Establishment’s commitment to strengthening the pharmaceutical sector’s readiness to respond to scientific developments and emerging treatments, reinforcing the UAE’s position among the leading countries in pharmaceutical regulation,” said Dr Ruqaya Al Bastaki, Acting Executive Director of the Medical Products Regulation Sector at the Emirates Drug Establishment, adding that its decision has been built on rigorous scientific assessment.

IgAN is the most common form of primary glomerular disease worldwide, which typically leads to end-stage kidney disease in up to 40% – 50% of all patients. It is also often associated with increased mortality, leading to a clear need for increased awareness and early treatment of the disease. In the United Arab Emirates, the number of IgAN diagnoses has steadily risen over several decades, placing increasing pressure on primary care physicians and nephrologists to develop nationwide solutions to optimize its clinical management.

Sameh El Fangary, Gulf Cluster President at AstraZeneca, noted that conditional approval of the new indication for Ultomiris is an important step towards expanding the treatment options available to patients.

“We look forward to continuing our collaboration with our partners in the UAE to support access to this treatment for eligible patients, helping improve treatment outcomes and enhance the quality of care they receive,” El Fangary said.

The Emirates Drug Establishment also emphasized the importance of healthcare providers spotting the disease early through regular monitoring of kidney function and frequent monitoring of protein levels in urine samples. The Establishment also stressed adhering to the treatment plan prescribed by a specialist physician to help monitor and manage the condition to reduce potential complications.