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Marstacimab-hncq

(Hympavzi®)

Hympavzi®

Drug updated on 10/23/2024

Dosage FormInjection (subcutaneous; 150 mg/mL in a single-dose prefilled syringe or prefilled pen)
Drug ClassTissue factor pathway inhibitor antagonists
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors.
  • Indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia B (congenital factor IX deficiency) without factor IX inhibitors.

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Summary
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  • This summary is based on the review of one randomized controlled trial(s). [1]
  • Hympavzi (marstacimab) reduced annualized bleeding rates (ABRs) in adults with severe haemophilia A and B, with mean ABRs ranging from 0 to 3.6 and median ABRs from 0 to 2.5 bleeding episodes per year across dose cohorts.
  • Participants included those with and without inhibitors, though specific effectiveness outcomes by subgroup were not reported.
  • The study’s effectiveness outcomes aligned with those observed in the short-term parent study.
  • Seventy percent of participants experienced treatment-emergent adverse events, including injection site reactions, injection site haematoma, and haemarthrosis.
  • No treatment-related serious adverse events, thrombotic events, or treatment-induced anti-drug antibodies were reported.
  • There is no population type or subgroup information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Hympavzi (marstacimab-hncq) Prescribing Information.2024Pfizer Inc., New York, NY

Randomized Controlled Trials

Document TitleSex DistributionYearSource
Long-term safety and efficacy of the anti-tissue factor pathway inhibitor marstacimab in participants with severe haemophilia: Phase II study results.
20Subjects
F: 0%
M: 100%
2023British Journal of Haematology

Document Title

Long-term safety and efficacy of the anti-tissue factor pathway inhibitor marstacimab in participants with severe haemophilia: Phase II study results.

Sex Distribution:

F:0%
M:100%
20Subjects

Year:

2023

Source:British Journal of Haematology