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FDA Approves Concizumab as Daily Prophylaxis for Hemophilia A and B

Summary by drugtopics.com
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.

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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…

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PR Newswire broke the news in United States on Thursday, July 31, 2025.
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