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Alhemo FDA Approval History

FDA Approved: Yes (First approved December 20, 2024)
Brand name: Alhemo
Generic name: concizumab-mtci
Dosage form: Injection
Company: Novo Nordisk
Treatment for: Hemophilia A with Inhibitors, Hemophilia B with Inhibitors, Hemophilia A, Hemophilia B

Alhemo (concizumab-mtci) is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A or B with or without inhibitors.

Development timeline for Alhemo

DateArticle
Jul 31, 2025Approval FDA Approves Alhemo as Once-Daily Prophylactic Treatment to Prevent or Reduce the Frequency of Bleeding Episodes for Adults and Children 12 Years of Age and Older with Hemophilia A or B (HA/HB) Without Inhibitors
Dec 20, 2024Approval FDA Approves Alhemo (concizumab-mtci) to Prevent or Reduce Bleeding Episodes in People with Hemophilia A or B with Inhibitors

Further information

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