BKEMV™

Understanding BKEMV™

BKEMV™ (eculizumab-aeeb) is a monoclonal antibody that inhibits the complement protein C5, a crucial component in the immune system’s complement pathway. By blocking C5, BKEMV™ prevents the formation of the terminal complement complex, reducing the destruction of red blood cells and mitigating damage to blood vessels. It is used to treat rare, life-threatening blood disorders where excessive complement activation leads to hemolysis and thrombotic microangiopathy.

How BKEMV™ Works:

• Binds to complement protein C5, inhibiting its cleavage into C5a and C5b.
• Prevents the formation of the membrane attack complex (C5b-9), reducing red blood cell destruction.
• Decreases hemolysis in paroxysmal nocturnal hemoglobinuria (PNH).
• Inhibits complement-mediated thrombotic microangiopathy in atypical hemolytic uremic syndrome (aHUS).

FDA Approval

• May 28, 2024 – Approved as the first interchangeable biosimilar to Soliris® (eculizumab) for:
  • Treatment of paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
  • Treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

BKEMV™ is available only through a restricted program called the BKEMV™ Risk Evaluation and Mitigation Strategy (REMS) due to the increased risk of serious meningococcal infections. Patients should complete meningococcal vaccination prior to initiating therapy and be monitored for early signs of infection.

For more information, please visit the BKEMV™ patient website. Speak with your healthcare provider to determine if BKEMV™ is the right treatment option for you.