UAE approves new drug for rare blood disorder that raises red blood cells and clot risk

Dubai: The UAE has approved a new treatment for adults living with polycythemia vera, a rare blood disorder in which the body makes too many red blood cells, raising the risk of dangerous blood clots.

The Emirates Drug Establishment (EDE) has cleared MIMRYLO (rusfertide), making the UAE the second country in the world to authorise the drug and widening the treatment options available to patients here.

Polycythemia vera is a rare, chronic condition in which the body produces a higher-than-normal number of red blood cells. This can make the blood thicker and increase the risk of clots and other complications.

MIMRYLO works by helping to reduce red blood cell levels in people with the condition, supporting its control and management, EDE said on Wednesday.

Limited treatment options

Dr Fatima Al Kaabi, Director General of the EDE, said the approval reflects the Establishment's commitment to building a regulatory model that can keep pace with advanced therapeutic innovation. She said the aim is to speed up access to such treatments through rigorous scientific assessment that puts patient safety at the heart of every decision.

She noted that this matters most in rare diseases, where treatment options remain limited for some groups of patients. The value of this approach, Al Kaabi added, lies in the efficiency of regulatory decisions and how well they respond to health priorities, helping to improve the quality of care and support better outcomes for patients.

Hernan Purcell, Regional General Manager for the Middle East and Turkey at Takeda Pharmaceuticals, called the approval an important milestone for people living with polycythemia vera.

He said it shows the company's commitment to developing medicines that address unmet medical needs. Purcell also commended the EDE for supporting pharmaceutical innovation and enabling patients to benefit from therapeutic advances in a timely manner.

How the treatment is given

MIMRYLO comes in single-dose vials containing a sterile lyophilised powder, which must be reconstituted before use. It should be given under the supervision of a healthcare provider experienced in managing the condition.

The EDE stressed that patients with polycythemia vera should follow their treating physician's instructions and prescribed treatment plan.

EDE also encouraged regular follow-ups with healthcare providers to support optimal disease management, improve quality of life and achieve the best possible treatment outcomes.