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FDA Medication Tracker

← All approvals · Heart & blood · 2024

Alhemo (concizumab-mtci)

The FDA approved Alhemo (concizumab-mtci) on December 20, 2024 For routine prophylaxis to prevent bleeding episodes in hemophilia A and B.
Brand name
Alhemo
Generic name
concizumab-mtci
FDA approval date
December 20, 2024
Approved use (FDA wording)
For routine prophylaxis to prevent bleeding episodes in hemophilia A and B
Company
Novo Nordisk Inc.
Application
BLA761315
Dosage form / route
Injectable · Subcutaneous
Drug class (EPC)
Tissue Factor Pathway Inhibitor Antagonist [EPC]
Boxed warning on label
Not listed
Category on this site
Heart & blood

Indications and usage, from the FDA label

Alhemo is 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) with or without FVIII inhibitors • hemophilia B (congenital factor IX deficiency) with or without FIX inhibitors Alhemo is a tissue factor pathway inhibitor (TFPI) antagonist 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) with or without FVIII inhibitors • hemophilia B (congenital factor IX deficiency) with or without FIX inh…

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.