---
title: "Pfizer Says FDA Approves Expanded HYMPAVZI Indication For Hemophilia A And B"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/289046752.md"
description: "Pfizer announced that the FDA has approved an expanded indication for HYMPAVZI (marstacimab-hncq) to treat hemophilia A and B. The approval covers adults and pediatric patients aged 6 and older, including those with inhibitors. This expansion allows for routine prophylaxis to prevent bleeding episodes via once-weekly subcutaneous administration, supported by Phase 3 trial results demonstrating significant reductions in annualized bleeding rates."
datetime: "2026-06-08T11:20:24.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/289046752.md)
  - [en](https://longbridge.com/en/news/289046752.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/289046752.md)
---

# Pfizer Says FDA Approves Expanded HYMPAVZI Indication For Hemophilia A And B

(RTTNews) - Pfizer, Inc. (PFE) announced Monday that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for HYMPAVZI (marstacimab-hncq) to include the treatment of patients with hemophilia A or B 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without inhibitors.

HYMPAVZI is now indicated in the U.S. for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with hemophilia A with or without factor VIII inhibitors, or hemophilia B with or without factor IX inhibitors.

HYMPAVZI offers a combination of prophylactic bleed protection with a straightforward, once-weekly subcutaneous administration that does not require routine treatment-related lab monitoring.

Results from the Phase 3 BASIS trial (NCT03938792) supported the approval of HYMPAVZI in adults and adolescents 12 years and older with hemophilia A or B with inhibitors.

The results demonstrated the superiority of HYMPAVZI in improving key bleeding outcomes including significantly reducing mean treated annualized bleeding rate (ABR) by 93% compared to on-demand (OD) intravenous treatment with bypassing agents.

Meanwhile, interim results from the Phase 3 BASIS KIDS trial (NCT05611801) supported the approval of HYMPAVZI in children ages 6 to 17 years with hemophilia A or B with or without inhibitors.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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