Arabian Post Staff -Dubai
The Emirates Drug Establishment announced on Tuesday that ravulizumab, marketed as Ultomiris, may be used to reduce proteinuria in adults with primary immunoglobulin A nephropathy, or IgAN, who are at risk of disease progression. Proteinuria refers to excess protein in urine, a marker of kidney damage.
The regulator described the UAE as the first country to approve the indication. However, AstraZeneca announced on 21 October that the United States Food and Drug Administration had already granted accelerated approval for the same medicine and patient group. The US prescribing information, updated on 29 October, confirms that authorisation. The UAE’s global-first claim therefore conflicts with the documented American decision.
Both decisions concern reducing proteinuria rather than establishing that the medicine prevents kidney failure. The US regulator explicitly states that it has not yet been demonstrated whether Ultomiris slows the decline in kidney function among patients with IgAN. Continued American approval may depend on confirmation of clinical benefit in an ongoing trial.
The UAE establishment did not specify in its announcement what additional evidence or monitoring requirements attach to its conditional authorisation. It also did not provide a timetable for wider patient access, pricing details or an estimate of how many people in the country might qualify for treatment.
The approval follows findings from the Phase III I CAN study, which assessed Ultomiris against placebo in adults with the disease. AstraZeneca said an interim analysis showed a placebo-adjusted reduction in proteinuria of 43.4 per cent after 34 weeks. The result measures a biological indicator associated with disease progression, not a confirmed reduction in kidney failure.
The study is continuing to examine changes in kidney function, with its principal assessment scheduled at 106 weeks. These longer-term findings are intended to determine whether the observed reduction in urinary protein translates into meaningful preservation of kidney function.
IgAN develops when abnormal immunoglobulin A forms deposits in the kidneys, triggering inflammation and damaging the structures responsible for filtering blood. The condition can progress over time, although its course varies between patients. Persistent proteinuria is among the indicators doctors use to assess risk and guide treatment.
Ultomiris works by inhibiting complement protein C5, part of the immune system involved in inflammatory damage. It is administered by intravenous infusion, generally every eight weeks after an initial loading dose, with dosing determined by body weight. The medicine was already registered in the UAE in 2022 for several rare diseases.
Safety remains an important consideration. US prescribing information carries a prominent warning that Ultomiris increases the risk of serious, potentially life-threatening meningococcal infections. Vaccination is required before treatment under specified conditions, and patients must be monitored for symptoms even when vaccinated. The warning is relevant to clinicians assessing the balance between potential benefit and risk.
AstraZeneca said upper respiratory tract infections, inflammation of the nose and throat and infusion-related reactions were among the adverse events recorded in the trial. The company said the interim safety findings were consistent with the medicine’s established profile, without identifying new safety concerns.
Ruqaya Aqeel Al Bastaki, Acting Executive Director of the Medical Products Regulation Sector at the Emirates Drug Establishment, said the decision reflected a regulatory approach combining scientific assessment with requirements for quality, safety and efficacy. She linked the approval to efforts to respond more quickly to developments in pharmaceutical treatment.
Sameh El Fangary, AstraZeneca’s Gulf Cluster President, welcomed the conditional authorisation as an expansion of options for eligible patients. He said the company intended to work with partners in the UAE to support access to the treatment and improve standards of care.
The establishment connected its decision with the We the UAE 2031 strategy, which includes strengthening healthcare capabilities, pharmaceutical innovation and research. Its announcement placed particular emphasis on accelerating access to medicines while maintaining regulatory oversight.
Such assessments can help identify patients whose disease is advancing despite existing care and inform decisions about whether additional treatment is appropriate.
The regulator also urged patients and clinicians to prioritise early diagnosis, regular kidney-function testing and measurements of urinary protein. It stressed that treatment should follow plans prescribed by specialist physicians, with continued monitoring to detect deterioration and manage complications.
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