[News Brief] Pfizer Receives FDA Approval for Expanded Hympavzi Use

Pfizer Receives FDA Approval for Expanded Hympavzi Use

Pfizer has received US Food and Drug Administration (FDA) approval for an expanded indication of Hympavzi (marstacimab-hncq) for adults and paediatric patients aged six years and older with haemophilia A or B, with or without inhibitors.

  •  Expanded Indication: Hympavzi is now approved for routine prophylaxis to prevent or reduce bleeding episodes in adults and paediatric patients aged six years and older with haemophilia A or B, with or without inhibitors.
  •  Treatment Approach: Hympavzi is a once-weekly subcutaneous non-factor therapy that targets tissue factor pathway inhibitor (TFPI).
  • Clinical Data: The expanded approval was supported by Phase 3 BASIS and BASIS KIDS data, including a 93 per cent reduction in mean treated annualised bleeding rate compared with on-demand intravenous bypassing agents.

This summary is based on a news article published by BioSpectrum Asia.

Image for illustrative purposes only. Source: Canva.


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