Drug updated on 10/23/2024
| Dosage Form | Injection (subcutaneous; 150 mg/mL in a single-dose prefilled syringe or prefilled pen) |
| Drug Class | Tissue 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.
Latest News
Summary
- 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 Title | Year | Source |
|---|---|---|
| Hympavzi (marstacimab-hncq) Prescribing Information. | 2024 | Pfizer Inc., New York, NY |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| 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% | 2023 | British Journal of Haematology |
Sex Distribution:
F:0%
M:100%
20Subjects
Year:
2023
Source:British Journal of Haematology