EC marketing authorisation granted to Pfizer's HYMPAVZI for haemophilia [Yahoo! Finance]
Pfizer, Inc. (PFE)
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Source: Yahoo! Finance
treat prophylaxis of bleeding incidents in individuals aged 12 years and above weighing a minimum of 35kg with severe haemophilia A without factor IX (FIX) inhibitors. HYMPAVZI is the first anti-TFPI approved in the EU for this indication and the first therapy to be administered through a pre-filled auto-injector pen. The authorisation is based on outcomes from the Phase III BASIS trial. This pivotal study demonstrated the safety and efficacy of marstacimab in decreasing the annualised bleeding rate by 35% compared to routine prophylaxis. The authorisation extends to all 27 EU member states, along with Liechtenstein, Iceland, and Norway. Pfizer chief international commercial officer and executive vice-president Alexandre de Germay stated: “HYMPAVZI offers a first-in-class treatment option for people living with haemophilia, a disease that often leads to recurring joint bleeds and can impact daily activities as simple as climbing stairs. “This approval builds on Pfizer's more
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PFE
Earnings
- 10/29/24 - Beat
PFE
Sec Filings
- 11/18/24 - Form 4
- 11/18/24 - Form 4
- 11/4/24 - Form 10-Q
- PFE's page on the SEC website