Emicizumab

Emicizumab, sold under the brand name Hemlibra, is a humanized bispecific monoclonal antibody for the treatment of haemophilia A, developed by Genentech and Chugai (a subsidiary of Hoffmann-La Roche). A Phase I clinical trial found that it was well tolerated by healthy subjects.

Emicizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetActivated factor IX, factor X
Clinical data
Trade namesHemlibra
Other namesACE910, RG6013, emicizumab-kxwh
AHFS/Drugs.comMonograph
License data
Pregnancy
category
  • AU: B2
Routes of
administration
Subcutaneous
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • CA: ℞-only / Schedule D
  • US: WARNINGRx-only
  • EU: Rx-only
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6434H9940N1724O2047S45
Molar mass145639.02 g·mol−1

In November 2017, it was approved in the United States for treatment of haemophilia A in those who had developed resistance to other treatments. It was subsequently approved by the US FDA in April 2018 under the breakthrough therapy designation for treatment of haemophila A in those who have not developed resistance to other treatments. The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.

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