Efanesoctocog Alfa Approved for Preventing and Treating Bleeding in Hemophilia A
February 14, 2025
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for efanesoctocog alfa (Eloctate®), a recombinant factor VIIIa therapy indicated for preventing and treating bleeding episodes in children and adults with severe or moderately severe hemophilia A.
Hemophilia A is a rare genetic bleeding disorder caused by a deficiency or dysfunction of clotting factor VIII, a protein that plays a crucial role in blood clot formation. Individuals with hemophilia A experience uncontrolled bleeding that can occur spontaneously or after an injury or surgery.
Key Features of Efanesoctocog Alfa
- Extended half-life: Efanesoctocog alfa has an extended half-life of approximately 1.4 hours, enabling less frequent dosing and providing longer-lasting protection against bleeding.
- Subcutaneous administration: Unlike traditional factor VIII products, efanesoctocog alfa is administered subcutaneously (under the skin), offering greater convenience and flexibility for patients.
- Sustained protection: Clinical studies have demonstrated that efanesoctocog alfa provides sustained protection against bleeding episodes, reducing the frequency and severity of bleeding events.
- Good safety profile: Efanesoctocog alfa has been well-tolerated in clinical trials, with a low incidence of adverse events.
Benefits for Patients
The approval of efanesoctocog alfa represents a significant advancement in the treatment of hemophilia A. It offers the following benefits for patients:
- Reduced bleeding episodes
- Enhanced quality of life
- Improved joint health
- Greater flexibility and convenience in administration
Dosage and Administration
Efanesoctocog alfa is administered subcutaneously once or twice weekly, depending on the severity of the patient’s condition. The dosage is individualized based on body weight and clinical response.
Conclusion
The availability of efanesoctocog alfa provides a new hope for children and adults with severe or moderately severe hemophilia A. Its extended half-life, subcutaneous administration, sustained protection, and good safety profile make it a valuable addition to the therapeutic arsenal for managing this bleeding disorder.
Efanesoctocog alfa approved to prevent and treat bleeding in children and adults with severe or moderate haemophilia A
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