Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
For or without FVIII inhibitors. Sold as Alhemo. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Concizumab-Mtci (sold as Alhemo), first approved Dec 20, 2024, with 0 new uses approved and 1 published complete response letter.
First approved: Dec 20, 2024
Applications: 1
New uses approved: 0
Complete response letters: 1
Medicare spending, 2025: $1.6M
Orphan exclusivity until: Jul 31, 2032
First approved in the EU: Dec 13, 2024
First approved in Japan: Sep 25, 2023
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 15 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
AlhemoDrugs with a new indication for the control of bleeding tendency in patients with congenital haemophilia who do not have inhibitors against blood… · Novo Nordisk Pharma Ltd. · Jun 24, 2024
Alhemo, new ingredientDrugs with a new active ingredient indicated for the control of bleeding tendency in patients with congenital haemophilia who have inhibitors against blood… · Novo Nordisk Pharma Ltd. · Sep 25, 2023 · Review report
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history
NNC0172-2021Clinical And Clinical Pharmacology, Device, Product Quality
Approved
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
