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Approval Alert: Pfizer’s Hympavzi™ (Marstacimab) Approved in Australia

Jan 29, 2025

On 29 January 2025, the Australian Therapeutic Goods Administration (TGA) approved Pfizer’s Hympavzi™ (marstacimab) in 150mg/mL solution for injection, prefilled pen, indicated for routine prophylaxis of bleeding episodes in patients 12 years of age and older with: severe haemophilia A without factor VIII inhibitors, or severe haemophilia B without factor IX inhibitors.

Hympavzi™ was approved in the EU and US for the same indication in November 2024 and October 2024, respectively.