Product Dossier
HYMPAVZI
Product Dossier for HYMPAVZI (marstacimab, Pfizer). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Pfizer
- Active ingredient: marstacimab
- Therapeutic area: Haematology
- Same area: REVOLADE
- Same area: NOVICRIT
What it is
Hympavzi is a human monoclonal IgG1 antibody that inhibits tissue factor pathway inhibitor (TFPI) to enhance the extrinsic coagulation cascade. The medicine is supplied as a 150 mg/mL solution for injection in a prefilled pen.
Approved indications —
Routine prophylaxis of bleeding episodes in patients 12 years of age and older with severe haemophilia A (congenital factor VIII deficiency, FVIII < 1%) without factor VIII inhibitors. — Routine prophylaxis of bleeding episodes in patients 12 years of age and older with severe haemophilia B (congenital factor IX deficiency, FIX < 1%) without factor IX inhibitors.
Regulatory history
The TGA approved Hympavzi on 29 January 2025. The medicine was first listed on the ARTG on 29 January 2025. This approval was part of an ACCESS Consortium work-sharing initiative.