The authorities of the United Arab Emirates (UAE) have approved a new medication, MIMRYLO, also known as rusfertide, intended for adults suffering from polycythemia vera.
This rare blood disorder causes the body to produce an excessive amount of red blood cells. These extra cells make the blood thicker, which increases the risk of thrombosis and other complications.
The approval was granted by the Emirates Drug Authority (EDE). According to this authority, the UAE has become the second country in the world to authorize this treatment.
What will change for patients
One method of treating this condition is regular blood removal to stabilize red blood cell levels. This procedure, called therapeutic phlebotomy, may need to be repeated depending on the patient's condition.
MIMRYLO helps control the production of excess red blood cells by regulating the body's iron absorption. According to Takeda, clinical trials demonstrated that the drug helped control red blood cell levels, reduce the need for blood removal procedures, and improve fatigue.
This approval provides doctors with an additional therapeutic option for adults with this disease. However, the UAE announcement did not specify when patients can access the drug, what its local cost will be, or if it is covered by insurance.
Another treatment option
Dr. Fatima Al Kaabi, CEO of EDE, noted that this decision reflects the authority's commitment to helping patients access advanced treatments through a scientific evaluation process that prioritizes safety. She emphasized that this is particularly important for rare diseases, where some patients have limited treatment options. Dr. Al Kaabi added that timely regulatory decisions can contribute to improved care and better outcomes.
Hernan Purcell, Regional General Manager of Takeda Pharmaceuticals for the Middle East and Turkey, stated that this approval is an important milestone for people living with polycythemia vera. He also highlighted the role of EDE in supporting access to new treatments.
The drug is supplied in single-dose vials containing powder that must be prepared before use. EDE specified that administration must be carried out under the supervision of a healthcare professional experienced in managing this disease. The authority strongly urged patients to follow their doctor's prescribed treatment plan and attend regular check-ups to keep the condition under control.