Novo Nordisk gets MHRA nod for Concizumab to prevent bleeding episodes frequency
Novo Nordisk has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for the medicine concizumab (brand name: Alhemo) to prevent or reduce the frequency of bleeding episodes (prophylaxis) in people aged 12 years and older with haemophilia A or B with inhibitors.
Haemophilia is a rare, inherited condition that affects the way blood clots. People with haemophilia A or B are at higher risk of bleeding because they lack proteins that help the blood clot (clotting factor VIII for haemophilia A and clotting factor IX for haemophilia B).
The active substance, concizumab, which acts independently of factor VIII and factor IX, works by blocking a natural protein that prevents blood from clotting (known as tissue factor pathway inhibitor). By inhibiting this protein, concizumab increases Factor Xa activity, a component in the blood clotting (coagulation) process, allowing the blood to clot more effectively and prevent bleeding in people with haemophilia.
Concizumab is injected subcutaneously (under the skin) daily.
As with any medicine, the MHRA will keep the safety and effectiveness of concizumab under close review.
"Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme," the release stated.
Concizumab has been approved through the International Recognition Procedure (IRP). The IRP allows the MHRA to take into account the expertise and decision-making of trusted regulatory partners for the benefit of UK patients. The MHRA retains the authority to reject applications if the evidence provided is not considered sufficiently robust.
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. The MHRA is an executive agency of the Department of Health and Social Care.
