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# Novo Nordisk Hemophilia Drug Expanded Approval
- URL: https://www.fdaweb.com/novo-nordisk-hemophilia-drug-expanded-approval/
- Published: 2025-08-01T12:00:00.000Z
- Updated: 2026-09-14T15:18:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159614

FDA has approved Novo Nordisk’s Alhemo (concizumab-mtci) as a once-daily preventive treatment for bleeding episodes in patients 12 years and older with hemophilia A or B without inhibitors. The action expands on the drug’s initial FDA approval in December 2024 for patients with inhibitors.

The approval was based on data from the Phase 3 Explorer8 trial, which showed that Alhemo significantly reduced the annualized bleeding rate (ABR) in patients receiving daily prophylaxis compared to those receiving no prophylaxis, the company says. Key findings from the trial include a 79% reduction in ABR for patients with hemophilia B, and an 86% reduction in ABR for patients with hemophilia A.