Alhemo concizumab-mtci APPROVED
Drug Profile
ModalityAntibody
RouteSC
Therapy AreaHematology
Launch2024-12-20
Peak Sales Est$1500M
Formulations[{"id":"alhemo-sc","doses":"Individualized based on drug concentration monitoring at week 4","route"
Companies
NVO (ORIGINATOR)100%
Mechanism: Anti-TFPI (tissue factor pathway inhibitor) antibody
Expert: Monoclonal antibody targeting tissue factor pathway inhibitor (TFPI). By neutralizing TFPI, it removes the negative regulation of the extrinsic pathway, enabling increased thrombin generation through the TF/FVIIa/FXa pathway, bypassing the need for FVIIIa in the intrinsic pathway.
Everyday: Removes a natural brake on clotting. Normally, TFPI slows down clotting — which is fine if your clotting system works. But in hemophilia, the clotting system is already weak, so removing this brake helps compensate. Like taking the parking brake off a car that already has a weak engine.
Targets: []
Programs (2)
IndicationStageKey StudyRegional Status
Hem A/B with inhibitorsAPPROVEDExplorer7[{"stage":"APPROVED","region":"US","approval_date":"2024-12-20"}]
Hem A/B without inhibitorsAPPROVEDExplorer8[{"stage":"APPROVED","region":"US","approval_date":"2025-07"}]
Notes
Anti-TFPI monoclonal antibody. First approved for Hem A/B WITH inhibitors (Dec 2024), then expanded to WITHOUT inhibitors (Jul 2025). Different MOA than Hemlibra/Mim8 — targets extrinsic pathway rather than mimicking FVIII. Drawback: requires daily injection and drug level monitoring at week 4. Advantage: works in both Hem A AND Hem B.
Safety Profile
{"notes":"Had a clinical hold in 2020 due to non-fatal thromboembolic events. Resumed with modified dosing protocol.","key_risks":["Injection site reactions","Thromboembolic events (clinical hold in 2020, resolved)","Requires drug concentration monitoring for dose adjustment"]}
Data from Supabase · Updated 2026-03-24