FDA Expands Approval of Concizumab-Mtci to Include Hemophilia A, B Without Inhibitor Use

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

FDA approval is based on phase 3 trial data (explorer8), which established the safety and efficacy of Alhemo® (concizumab-mtci) injection in people 12 years and older with hemophilia A or B (HA/HB) without inhibitors1Results showed a 79% reduction in annualized…

What Alhemo Means for Patients With Hemophilia A and B Without Inhibitors

The FDA's approval of Alhemo (concizumab-mtci) revolutionizes hemophilia treatment, offering a simpler, subcutaneous injection for better bleed control and patient independence.

FDA expands approval of Alhemo to help more people with hemophilia

The U.S. Food and Drug Administration (FDA) has expanded its approval of Alhemo (concizumab-mtci), a daily therapy injected under the skin for preventing or reducing the frequency of bleeding episodes in people with hemophilia A or B, ages 12 and older. Sold by Novo Nordisk, Alhemo had been approved in the U.S. only for patients with inhibitors, that is, neutralizing antibodies that can lower the effectiveness of standard hemophilia treatments. …

FDA Expands Approval of Concizumab-mtci to Include Hemophilia A, B Without Inhibitor Use

The approval builds upon concizumab’s previous December 2024 clearance and allows for treatment in patients with hemophilia A or B, both with or without inhibitors.

FDA Approves Concizumab as Daily Prophylaxis for Hemophilia A and B

Many treatments for hemophilia A and B are administered via intravenous infusions, so the approval offers a subcutaneous injection for the treatment for patients 12 years and older.

FDA approves concizumab-mtci for hemophilia A/B without inhibitors in patients 12 years and older

The FDA approved concizumab-mtci (Alhemo; Novo Nordisk) for hemophilia A/B without inhibitors, offering once-daily subcutaneous prophylaxis that significantly reduces bleeding rates.