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.

• 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.

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Development timeline for Alhemo

Further information

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