Pfizer. U.S. FDA approves Pfizer’s HYMPAVZI™ (marstacimab-hncq) for the treatment of adults and adolescents with hemophilia A or B without inhibitors [media release]. 11 Oct 2024. https://www.pfizer.com/.
Pfizer Inc. HYMPAVZI (marstacimab-hncq) injection, for subcutaneous use. 2024. https://labeling.pfizer.com/ShowLabeling.aspx?id=20916. Accessed 18 Oct 2024.
U.S. Food & Drug Administration. FDA approves new treatment for hemophilia A or B [media release]. 11 Oct 2024. https://www.fda.gov/.
Centers for Disease Control and Prevention. Hemophilia. 2024. https://www.cdc.gov/hemophilia/. Accessed 14 Oct 2024.
Franchini M, Mannucci PM. Past, present and future of hemophilia: a narrative review. Orphanet J Rare Dis. 2012;7(1):1–8.
Nogami K, Shima M. Current and future therapies for haemophilia-beyond factor replacement therapies. Br J Haematol. 2023;200(1):23–34.
Article CAS PubMed Google Scholar
Mancuso ME, Croteau SE, Klamroth R. Benefits and risks of non-factor therapies: redefining haemophilia treatment goals in the era of new technologies. Haemophilia. 2024;30(S3):39–44.
Thornburg CD, Duncan NA. Treatment adherence in hemophilia. Patient Prefer Adher. 2017;11:1677–86.
Young G. Nonfactor therapies for hemophilia. HemaSphere. 2023;7(6):1–4.
Patel-Hett S, Martin EJ, Mohammed BM, et al. Marstacimab, a tissue factor pathway inhibitor neutralizing antibody, improves coagulation parameters of ex vivo dosed haemophilic blood and plasmas. Haemophilia. 2019;25(5):797–806.
Article CAS PubMed Google Scholar
Mahlangu J, Luis Lamas J, Cristobal Morales J, et al. Long-term safety and efficacy of the anti-tissue factor pathway inhibitor marstacimab in participants with severe haemophilia: phase II study results. Br J Haematol. 2023;200(2):240–8.
Article CAS PubMed Google Scholar
Parng C, Singh P, Pittman DD, et al. Translational pharmacokinetic/pharmacodynamic characterization and target-mediated drug disposition modeling of an anti–tissue factor pathway inhibitor antibody, PF-06741086. J Pharm Sci. 2018;107(7):1995–2004.
Article CAS PubMed Google Scholar
Pfizer Inc. European Commission approves Pfizer's HYMPAVZI™ (marstacimab) for the treatment of adults and adolescents with severe hemophilia A or B without inhibitors [media release]. 20 Nov 2024. https://www.pfizer.com/.
World Intellectual Property Organisation (WIPO). Dosage regimen for tfpi antagonists. 2020. https://patents.google.com/patent/WO2020075083A1/. Accessed 26 Sep 2024.
World Intellectual Property Organisation (WIPO). Stable aqueous anti-tfpi antibody formulation. 2021. https://patents.google.com/patent/WO2021094917A1/. Accessed 26 Sep 2024.
Cardinal M, Kantaridis C, Zhu T, et al. A first-in-human study of the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06741086, an anti-tissue factor pathway inhibitor mAb, in healthy volunteers. J Thromb Haemost. 2018;16(9):1722–31.
Article CAS PubMed Google Scholar
Sun X, Liu W, Luo B, et al. Safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of marstacimab in Chinese participants with severe haemophilia. Haemophilia. 2023;29(4):1155–9.
Article CAS PubMed Google Scholar
Mahlangu JN, Lamas JL, Morales JC, et al. A phase 1b/2 clinical study of marstacimab, targeting human tissue factor pathway inhibitor, in haemophilia. Br J Haematol. 2023;200(2):229–39.
Article CAS PubMed Google Scholar
Pittman DD, Rakhe S, Bowley SR, et al. Hemostatic efficacy of marstacimab alone or in combination with bypassing agents in hemophilia plasmas and a mouse bleeding model. Res Pract Thromb Haemost. 2022;6(2):1–10.
Raje S, Plotka A, Huyghe I, Teeter J. Bioequivalence (BE) of marstacimab prefilled pen (PFP) device and prefilled syringe (PFS) device following subcutaneous (SC) administration in healthy adult males [abstract no. PO036]. Haemophilia. 2022;28(S1):41–2.
Acharya SS, Matino D, Palladino A, et al. Safety and efficacy of the anti-tissue factor pathway inhibitor marstacimab in participants with severe hemophilia without inhibitors: results from the phase 3 BASIS trial and ongoing long-term extension study [abstract no. 206 + poster]. In: Thrombosis & Hemostasis Societies of North America (THSNA) Summit, April 4–6. 2024.
Matino D, Acharya S, Palladino A, et al. Efficacy and safety of the anti-tissue factor pathway inhibitor marstacimab in participants with severe hemophilia without inhibitors: results from the phase 3 Basis trial [abstract]. Blood. 2023;142(Suppl. 1):285–7.
Acharya S, Matino D, Mahlangu J, et al. Marstacimab, an anti-tissue factor pathway inhibitor, in participants with hemophilia Α or B, with and without inhibitors: an integrated analysis of safety [abstract]. Blood. 2023;142(Suppl. 1):3980–2.
Teeter J, Charnigo R, Cossons N, et al. Safety and efficacy of marstacimab for prevention of bleeding episodes in paediatric patients with severe haemophilia A or moderately severe to severe haemophilia B with or without inhibitors [abstract no. PO122]. Haemophilia. 2022;28(S1):88–9.
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