Public RecordRecord
UAE approves rusfertide for polycythemia vera treatment
Emirates Drug Establishment authorises MIMRYLO as second country globally to clear the medicine for adults with the rare blood disorder.
The Emirates Drug Establishment approved MIMRYLO, also known as rusfertide, for adults with polycythemia vera on 30 September 2026. The UAE is the second country globally to authorise the treatment, according to the establishment's announcement.
Rusfertide approval for polycythemia vera in UAE#
Polycythemia vera causes the body to produce more red blood cells than needed. The excess cells thicken the blood and raise the risk of blood clots and other complications. Doctors manage the condition by regularly removing blood through therapeutic phlebotomy to control red blood cell levels. The frequency of the procedure depends on the patient's condition. MIMRYLO regulates how the body uses iron to control the production of excess red blood cells. Clinical trials conducted by Takeda demonstrated that rusfertide controlled red blood cell levels, lowered the frequency of blood-removal procedures and reduced fatigue in patients, according to the company's published data.
Emirates Drug Establishment authorisation process#
Dr Fatima Al Kaabi, director general of the Emirates Drug Establishment, said the authorisation demonstrated the regulator's focus on bringing advanced treatments to patients through a science-based assessment that puts safety first. She noted the importance of timely regulatory decisions for rare diseases where some patients have limited treatment options. The medicine comes in single-dose vials containing a powder that must be prepared before use. The establishment specified it should be administered under the supervision of a healthcare provider experienced in managing polycythemia vera.
Treatment availability and administration requirements#
The announcement did not state when the medicine would become available to patients, what it would cost locally or whether insurers would cover it. Hernan Purcell, regional general manager for the Middle East and Turkey at Takeda Pharmaceuticals, described the approval as an important milestone for people living with polycythemia vera. The regulator advised patients to adhere to the treatment plan their doctor prescribes and to maintain regular monitoring appointments for ongoing disease management.
Polycythemia vera management options#
The approval gives doctors another treatment option for adults living with the condition. Therapeutic phlebotomy remains a standard management approach, with the procedure repeated as needed based on red blood cell levels. The medicine's mechanism targets iron regulation to address the underlying production of excess red blood cells rather than removing blood after it has been produced. Takeda's clinical trial data showed patients using rusfertide required fewer phlebotomy procedures compared with standard management. The medicine is administered by injection under medical supervision.
Sources1 source across 1 domain
- khaleejtimes.comKhaleej TimesEmirates Drug Establishment approved MIMRYLO (rusfertide) for polycythemia vera on 30 September 2026, making UAE the second country globally to authorise the treatment
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