Words by Jade Williams
The first and only anti-tissue factor pathway inhibitor (anti-TFPI) has been approved in the EU for the treatment of haemophilia A and B, with Pfizer’s drug gaining marketing authorisation by the European Commission.
This approval makes marstacimab not only the first anti-TFPI, but also the first haemophilia medicine in the EU to be administered via a pre-filled auto-injector pen – offering convenient, once-weekly subcutaneous dosing with minimal preparation for each administration.
“There is a considerable treatment burden associated with the standard-of-care options for hemophilia A and B, including time-consuming preparation and administration of infusions and injections potentially causing missed doses and an increased risk of bleeding,” said Dr Laurent Frenzel, Head of the Hemophilia Treatment and Research Center, Necker-Enfants Malades Hospital, in a press release. Continuing, he called the approval a “significant advancement” for people with haemophilia.
Also commenting in the press release, Alexandre de Germay, Chief International Commercial Officer and Executive Vice President, Pfizer, said: “This approval builds on Pfizer’s more than four-decade commitment to improve the standard of care in hemophilia, and we look forward to delivering this medicine”.
The approval is valid across all 27 EU member states, as well as Iceland, Liechtenstein and Norway, and follows the US approval by the FDA in October 2023.
