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With this approval, the UAE becomes the second country globally to authorise the treatment, reinforcing its position among countries at the forefront of providing modern therapies for rare diseases and supporting broader access to treatment options that address the needs of these patients.
Polycythemia vera is a rare, chronic blood disorder characterised by the production of a higher-than-normal number of red blood cells, which can increase blood viscosity and raise the risk of blood clots and other complications. MIMRYLO helps reduce red blood cell levels in people with the condition, supporting its control and management.
Her Excellency Dr Fatima Al Kaabi, Director General of the Emirates Drug Establishment, said the approval of MIMRYLO reflects the Establishment’s commitment to developing a regulatory model capable of keeping pace with advanced therapeutic innovation and accelerating access to such treatments through rigorous scientific assessment that places patient safety at the heart of regulatory decision-making.
Her Excellency noted that this is particularly important in rare diseases, where treatment options remain limited for some groups of patients. Al Kaabi added that the value of this approach lies in the efficiency of regulatory decisions and their responsiveness to health priorities, helping enhance the quality of care and support better treatment outcomes for patients.
Meanwhile, Hernan Purcell, Regional General Manager for the Middle East and Turkey at Takeda Pharmaceuticals, said the approval of MIMRYLO marks an important milestone for people living with polycythemia vera and demonstrates the company’s commitment to developing medicines that address unmet medical needs. Purcell commended the Emirates Drug Establishment’s role in supporting pharmaceutical innovation and enabling patients to benefit from therapeutic advances in a timely manner.
MIMRYLO is available in single-dose vials containing a sterile lyophilised powder for reconstitution before use. It should be administered under the supervision of a healthcare provider experienced in managing the condition.
The Emirates Drug Establishment emphasised the importance of patients with polycythemia vera adhering to their treating physician’s instructions and prescribed treatment plan. It also encouraged regular follow-up with healthcare providers to support optimal disease management, enhance quality of life and achieve the best possible treatment outcomes.