Treatment for haemophilia patients: The Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for the medicine marstacimab (Hympavzi) to prevent or reduce bleeding in patients aged 12 years and above, weighing at least 35kg, with haemophilia A or B. Marstacimab is a novel treatment that works by targeting tissue factor pathway inhibitor (TFPI), a protein involved in the blood clotting process.
Haemophilia A and B
Haemophilia A and B are inherited bleeding disorders caused by a deficiency in factor VIII or factor IX, respectively. These proteins play a crucial role in blood clotting, and their deficiency can lead to prolonged bleeding. Some patients with haemophilia may develop inhibitors, which are antibodies that counteract replacement factor VIII or factor IX medicines, rendering them ineffective. Marstacimab is specifically designed for patients who have not developed these inhibitors.
Still on Treatment for haemophilia patients
Mechanism of Action
Marstacimab works by recognizing and attaching to TFPI, thereby reducing its activity. This allows for the formation of thrombin, a protein essential for blood clotting, which helps to increase clotting and stop bleeding in patients with haemophilia. By targeting TFPI, marstacimab provides a new approach to treating haemophilia A and B.
Approval and Dosage
The MHRA approval was based on evidence from a main study that evaluated marstacimab in 116 adults and adolescents aged 12 years and above with severe haemophilia A or B without inhibitors. The study demonstrated that marstacimab significantly reduced the annualized bleeding rate (ABR) for treated bleeds during the 12-month active treatment period. Marstacimab is administered via injection under the skin once weekly, using a pre-filled syringe or pen. Patients or carers can inject the medicine themselves after receiving appropriate training.
Safety and Side Effects
The most common side effects of marstacimab include headache, high blood pressure, and itching (pruritus). As with any medicine, the MHRA will continue to monitor the safety and effectiveness of marstacimab closely. Patients and healthcare professionals are encouraged to report any suspected side effects to the Yellow Card scheme.
MHRA Statement
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, emphasized the agency’s commitment to enabling access to safe, innovative, and effective medicines. He assured that the approval of marstacimab demonstrates the MHRA’s dedication to meeting the necessary regulatory standards while keeping patient safety under close review.
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