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FDA Medication Tracker

← All approvals · Heart & blood · 2024

Hympavzi (marstacimab-hncq)

The FDA approved Hympavzi (marstacimab-hncq) on October 11, 2024 to prevent or reduce bleeding episodes related to hemophilia A or B.
Brand name
Hympavzi
Generic name
marstacimab-hncq
FDA approval date
October 11, 2024
Approved use (FDA wording)
To prevent or reduce bleeding episodes related to hemophilia A or B
Company
Pfizer Inc.
Application
BLA761369
Dosage form / route
INJECTABLE · SUBCUTANEOUS
Boxed warning on label
Not listed
Category on this site
Heart & blood

Indications and usage, from the FDA label

HYMPAVZI is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with: • hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors, or • hemophilia B (congenital factor IX deficiency) with or without factor IX inhibitors. HYMPAVZI is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with: • hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors, or • hemophilia B (congenital factor IX defi…

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.