emicizumab

{{Short description|Monoclonal antibody}}

{{Use dmy dates|date=September 2024}}

{{cs1 config |name-list-style=vanc |display-authors=6}}

{{Infobox drug

| type = mab

| image = Emicizumab.png

| alt =

| mab_type = mab

| source = zu

| target = Activated factor IX, factor X

| pronounce =

| tradename = Hemlibra

| Drugs.com = {{drugs.com|monograph|emicizumab-kxwh}}

| MedlinePlus =

| DailyMedID = Emicizumab

| pregnancy_AU = B2

| pregnancy_AU_comment =

| pregnancy_category=

| routes_of_administration = Subcutaneous

| ATC_prefix = B02

| ATC_suffix = BX06

| legal_AU = S4

| legal_AU_comment = {{cite web |url=https://www.guildlink.com.au/gc/ws/ro/pi.cfm?product=rophemli10218 |title=AUSTRALIAN PRODUCT INFORMATION – Hemlibra (Emicizumab) |archive-url=https://web.archive.org/web/20230515185854/https://www.guildlink.com.au/gc/ws/ro/pi.cfm?product=rophemli10218 |archive-date=15 May 2023 |access-date=8 January 2023}}

| legal_CA = Rx-only

| legal_CA_comment = / Schedule D{{cite web | title=Summary Basis of Decision (SBD) for Hemlibra | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00411&lang=en | access-date=29 May 2022}}

| legal_UK =

| legal_US = Rx-only

| legal_EU = Rx-only

| legal_UN =

| legal_NZ =

| legal_status = Rx-only

| bioavailability =

| protein_bound =

| metabolism =

| metabolites =

| onset =

| elimination_half-life =

| duration_of_action =

| excretion =

| CAS_number = 1610943-06-0

| PubChem =

| ChemSpiderID = none

| DrugBank = DB13923

| UNII = 7NL2E3F6K3

| KEGG_Ref = {{keggcite|correct|kegg}}

| KEGG = D10821

| synonyms = ACE910, RG6013, emicizumab-kxwh

| C=6434|H=9940|N=1724|O=2047|S=45

}}

Emicizumab, sold under the brand name Hemlibra, is a humanized bispecific monoclonal antibody for the treatment of haemophilia A, developed by Genentech and Chugai (both organizations are subsidiaries of Hoffmann-La Roche).{{cite journal | vauthors = Spreitzer H | date = 4 July 2016 | title = Neue Wirkstoffe - Emicizumab | journal = Österreichische Apothekerzeitung | issue = 14/2016 | language = German }} A Phase I clinical trial found that it was well tolerated by healthy subjects.{{cite journal | vauthors = Uchida N, Sambe T, Yoneyama K, Fukazawa N, Kawanishi T, Kobayashi S, Shima M | title = A first-in-human phase 1 study of ACE910, a novel factor VIII-mimetic bispecific antibody, in healthy subjects | journal = Blood | volume = 127 | issue = 13 | pages = 1633–41 | date = March 2016 | pmid = 26626991 | pmc = 4817308 | doi = 10.1182/blood-2015-06-650226 }}

In November 2017, it was approved in the United States for treatment of haemophilia A in those who had developed resistance to other treatments.{{cite news|url=https://www.reuters.com/article/us-roche-hemlibra/roche-hemophilia-drug-wins-fda-nod-with-a-warning-idUSKBN1DG2C4|title=Roche hemophilia drug wins FDA nod, with a warning|date=17 November 2017|publisher=Reuters}} 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.{{Cite news|url=http://www.biopharminternational.com/fda-grants-roche-breakthrough-therapy-designation-hemophilia-drug|title=FDA Grants Roche Breakthrough Therapy Designation on Hemophilia Drug|last=|date=19 April 2018|work=BioPharm International|access-date=20 April 2018|publisher=UBM}} The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.{{cite report | title=New Drug Therapy Approvals 2017 | website=U.S. Food and Drug Administration (FDA) | date=January 2018 | url=https://www.fda.gov/media/110526/download | archive-url=https://web.archive.org/web/20190914090907/https://www.fda.gov/media/110526/download | url-status=dead | archive-date=14 September 2019 | format=PDF | access-date=16 September 2020}}

Studies indicate that emicizumab is a better therapy compared to the previous generations, due to subcutaneous administration and fewer injections, which reduces injection site reactions and makes therapy less troublesome.{{cite journal | vauthors = Grabowska K, Grzelak M, Zhao LY, Płuciennik E, Pasieka Z, Kciuk M, Gielecińska A, Smakosz AK, Kałuzińska-Kołat Ż, Kołat D | title = Emicizumab as a Promising Form of Therapy for Type A Hemophilia - A Review of Current Knowledge from Clinical Trials | journal = Current Protein & Peptide Science | volume = 25 | pages = 719–737 | date = May 2024 | issue = 9 | pmid = 38797909 | doi = 10.2174/0113892037294674240509094418 }}