emicizumab-kxwh (Hemlibra, ACE910)

^[1]^[2]^[3]^[4]

Indications

3 mg/kg SC weekly for the first 4 weeks, then 1.5 mg/kg SC weekly thereafter.^[2]^[4]

bispecific antibody that binds to activated factor IX & factor X, substituting for factor VIII

↑ Uchida N, Sambe T, Yoneyama K et al A first-in-human phase 1 study of ACE910, a novel factor VIII- mimetic bispecific antibody, in healthy subjects. Blood. 2016 Mar 31;127(13):1633-41. PMID: https://www.ncbi.nlm.nih.gov/pubmed/26626991 Free PMC Article
↑ ^2.0 ^2.1 Shima M et al. Factor VIII-mimetic function of humanized bispecific antibody in hemophilia A. N Engl J Med 2016 May 26; 374:2044. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27223146 <Internet> http://www.nejm.org/doi/10.1056/NEJMoa1511769
DiMichele DM. Hemophilia therapy - navigating speed bumps on the innovation highway. N Engl J Med 2016 May 26; 374:2087 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27223151 <Internet> http://www.nejm.org/doi/10.1056/NEJMoa1511769
↑ ^3.0 ^3.1 Oldenburg J, Mahlangu JN, Kim B et al Emicizumab Prophylaxis in Hemophilia A with Inhibitors. N Engl J Med 2017; 377:809-818. August 31, 2017 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28691557 Free Article <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1703068
↑ ^4.0 ^4.1 Windle ML. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review Medscape - Jan 11, 2018. https://reference.medscape.com/viewarticle/890871
U.S. Food and Drug Administration. Novel Drug Approvals for 2017. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm