EculizumabEculizumab (Soliris®) is a humanised monoclonal antibody that targets human C5 complement protein and inhibits the activation of terminal complement.
Eculizumab is a humanised monoclonal (IgG2/4κ) antibody produced in NS0 cell line by recombinant DNA technology that preventing generation of the terminal complement complex by inhibiting cleavage of complement protein C5.
Mechanism of action
Eculizumab specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9. Upon administration of eculizumab, the early components of complement activation that are essential for opsonization of microorganisms and clearance of immune complexes are preserved.
In PNH patients, treatment with eculizumab blocks complement-mediated intravascular haemolysis and in aHUS patients it inhibits complement- mediated thrombotic microangiopathy. Chronic administration of eculizumab in refractory gMG patients results in immediate, complete, and sustained inhibition of terminal complement activity, which would lead to membrane attack complex (MAC)-dependent lysis and C5a-dependent inflammation at the neuromuscular junction.
In Europe, eculizumab (Soliris®) is used to treat :
- adults and children with paroxysmal nocturnal haemoglobinuria (PNH)
- adults and children withatypical haemolytic uraemic syndrome (aHUS)
- adults with myasthenia gravis, in whom other medicines do not work and who are positive for AChR antibody.
Because these conditions are rare diseases, Soliris was designated an ‘orphan medicine’ for PNH, aHUS and for myasthenia gravis. Consult CHMP for details.
What can Sanquin do for you?
We can measure the levels of free drug in the serum; levels of therapeutic antibodies are assessed using validated ELISAs. As we have hands-on experience in these assays, we can provide you with accurate and reproducible test results.
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If you want to use our drug level testing services, email us at [email protected]