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Eculizumab

Generic Name
Eculizumab
Brand Names
Soliris, Epysqli, Bekemv
Drug Type
Biotech
CAS Number
219685-50-4
Unique Ingredient Identifier
A3ULP0F556

Overview

Eculizumab is a monoclonal antibody that targets complement protein C5. Binding to this protein prevents the activation of a complement terminal complex, which is used to treat a number of autoimmune conditions. Eculizumab was granted FDA approval on 16 March 2007. In Q1 2023, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of two formulations of eculizumab indicated for the treatment of paroxysmal nocturnal hemoglobinuria.

Background

Eculizumab is a monoclonal antibody that targets complement protein C5. Binding to this protein prevents the activation of a complement terminal complex, which is used to treat a number of autoimmune conditions. Eculizumab was granted FDA approval on 16 March 2007. In Q1 2023, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of two formulations of eculizumab indicated for the treatment of paroxysmal nocturnal hemoglobinuria.

Indication

Eculizumab is indicated in the US to treat paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy, and neuromyelitis optica spectrum disorder (NMOSD). It is also indicated in EU to treat PNH in both adult and pediatric patients.

Associated Conditions

  • Generalized Myasthenia Gravis
  • Neuromyelitis Optica Spectrum Disorders
  • Paroxysmal Nocturnal Haemoglobinuria (PNH)
  • Thrombotic Microangiopathies

FDA Approved Products

SOLIRIS
Manufacturer:Alexion Pharmaceuticals Inc.
Route:INTRAVENOUS
Strength:300 mg in 30 mL
Approved: 2024/03/28
NDC:25682-001

Singapore Approved Products

Soliris Concentrate for Solution for Infusion 300mg/vial
Manufacturer:Alexion Pharma International Operations Limited (AAMF), PATHEON ITALIA S.P.A
Form:INFUSION, SOLUTION CONCENTRATE
Strength:300 mg / vial
Online:Yes
Approved: 2012/09/12
Approval:SIN14226P

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