Eculizumab-aeeb (Bekemv)

General information

Class/mechanism: Complement inhibitor; monoclonal antibody that binds to complement protein C5, preventing its cleavage to C5a and C5b and the formation of the terminal complement complex C5b-9. Eculizumab is used in diseases involving abnormal complement-mediated activity, such as paroxysmal nocturnal hemoglobinuria (PNH) and complement-mediated thrombotic microangiopathy (TMA) in patients with atypical hemolytic uremic syndrome (aHUS).

Toxicity management

• Bkemv Risk Evaluation and Mitigation Strategy (REMS)

Diseases for which it is established

• Atypical hemolytic uremic syndrome (FDA)
• Paroxysmal nocturnal hemoglobinuria (EMA, FDA)

Diseases for which it is used

• Cold agglutinin disease

History of changes in FDA indication

• 2024-05-28: Approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
• 2024-05-28: Approved for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

History of changes in EMA indication

• 2023-04-19: Bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history.

Also known as

• Brand names: Bekemv, Bkemv