AstraZeneca’s Ultomiris (ravulizumab) has received conditional approval in the UAE for a new indication: reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression.
The Emirates Drug Establishment (EDE) granted the approval, adding to the drug’s existing UAE registration, which has been in place since 2022 for several rare diseases.
Primary IgA nephropathy is an immune-mediated kidney condition in which immune proteins deposit in kidney tissue, triggering inflammation and a gradual loss of kidney function. Elevated urinary protein levels are a recognised marker of disease progression, making treatment options that can reduce proteinuria clinically meaningful for managing 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.”
Sameh El Fangary, Gulf Cluster President at AstraZeneca, described the conditional approval as “an important step towards expanding the treatment options available to eligible patients in the UAE,” and said the company intends to continue working with local partners to support patient access and improve care outcomes.
EDE also called for early diagnosis, regular monitoring of kidney function and urinary protein levels, and strict adherence to specialist-prescribed treatment plans to reduce the risk of complications.
The approval is framed by the EDE as consistent with the UAE’s “We the UAE 2031” vision, which sets strengthening healthcare and pharmaceutical competitiveness as a strategic priority.
