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Newly Accepted Label to Assist Individuals with Hemophilia A

14th May 2024

The FDA accepted a revised label for the recoupling antihemophilic factor, Fc-VWF-XTEN fusion protein-ehtl, which now includes the complete findings from the phase 3 XTEND-Kids investigation. This research shows that administering the medication once a week protects paediatric haemophilia A patients from bleeding.

As stated in a press statement, the medication was originally authorised in february 2023 for use in surgical management, on-demand therapy, and regular prophylaxis in adults as well as kids. The complete research outcomes, which demonstrate the medication’s clinical utility as a therapy option for every individual affected, are included in the latest release.

“Hemophilia is a lifelong condition, so starting children on an early prophylactic regimen can help them stay ahead of bleeds and reduce other potential complications, such as joint damage and pain. Delivering significant bleed protection with a reduced treatment burden can allow families to spend more time on activities and less time focused on infusion schedules,” Mindy Simpson, MD, hematologist and assistant professor of pediatrics at Rush University Medical Center, stated.

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