10 Facts About Eculizumab

Eculizumab, sold under the brand name Soliris among others, is a medication used to treat paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, generalized myasthenia gravis, and neuromyelitis optica.

Eculizumab was the first drug approved for each of its uses, and its approval was granted based on small trials.

Eculizumab is used to treat atypical hemolytic uremic syndrome and paroxysmal nocturnal hemoglobinuria .

Eculizumab is used to treat neuromyelitis optica spectrum disorder in adults who are anti-aquaporin-4 antibody positive.

Eculizumab has been explored as a treatment for CD55 deficiency, known as CHAPLE syndrome, a rare genetic disorder of the immune system.

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Eculizumab is administered in a doctor's office or clinic by intravenous infusion.

Eculizumab carries a black box warning for the risk of meningococcal infections and can only be prescribed by doctors who have enrolled in and follow a risk evaluation and mitigation strategy required by the FDA, which involves doctors counseling people to whom they are prescribing the drug, giving them educational materials, and ensuring that they are vaccinated, all of which must be documented.

Eculizumab is a recombinant humanized monoclonal antibody against the complement protein C5.

Eculizumab was approved by the US Food and Drug Administration in March 2007 for the treatment of PNH, Eculizumab has exclusivity rights until 2017, which protects it from competition until 2017.

Eculizumab was approved by the FDA for AQP4+ NMO in 2019, based on the results of the PREVENT trial.