ALHEMO
Alhemo (concizumab-mtci) is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis in adult and pediatric patients 12 years of age and older. It is used to prevent or reduce the frequency of bleeding episodes in individuals with hemophilia A or hemophilia B. The treatment is applicable to patients regardless of whether they have developed inhibitory antibodies to factor VIII or factor IX.
How ALHEMO Works
Concizumab-mtci is a monoclonal antibody that acts as an antagonist to endogenous tissue factor pathway inhibitor (TFPI). By inhibiting TFPI, the drug enhances the production of factor Xa during the initiation phase of the coagulation process. This increase in factor Xa leads to improved thrombin generation and clot formation to achieve hemostasis. Because the drug has no structural relationship to factor VIII or factor IX, its effect is not influenced by the presence of inhibitors to those factors.
Details
- Status
- Prescription
- First Approved
- 2024-12-20
- Routes
- Subcutaneous, INJECTION
- Dosage Forms
- Injectable, SOLUTION
ALHEMO Approval History
What ALHEMO Treats
2 indicationsALHEMO is approved for 2 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hemophilia A
- Hemophilia B
ALHEMO Target & Pathway
ProTarget
The central enzyme in blood coagulation that converts fibrinogen to fibrin, forming blood clots. Direct thrombin inhibitors prevent clot formation and are used to prevent stroke and treat blood clots.
ALHEMO Competitors
Pro6 other drugs also target THROMBIN. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (THROMBIN). Earlier expiry dates signal biosimilar/generic opportunities.
Drugs Similar to ALHEMO
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ALHEMO FDA Label Details
ProIndications & Usage
FDA Label (PDF)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 ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.