Pfizer has been granted marketing authorisation for Hympavzi, a subcutaneous injectable suitable for treating bleeding episodes in patients with haemophilia A and B.
Hympavzi, otherwise known as marstacimab, is suitable for patients 12 years and up, providing they weigh at least 35kg.
Those eligible for marstacimab are patients with severe haemophilia A, or severe haemophilia B without FVIII/FIX inhibitors.
Enhancing patient centricity with Hympavzi
The drug, which can be administered via an autoinjector pen, is the first and only anti-tissue factor pathway inhibitor to be approved in the EU for this indication.
It is also the first self-administering haemophilia medicine to be approved in this region.
Hympavzi should be taken once weeky, and can be administered away from the hospital setting, making it a more patient-centric option than the current alternatives on the market.
Marketing authorisation from the European Commission was based on the results of the Phase III BASIS study, which found that Hympavzi could significantly reduce the annualised bleeding rate in patients by 35%.
The therapeutic also demonstrated both non-inferiority and superiority compared with routine prophylaxis methods currently available as standard of care to patients.
Pfizer can now market Hympavzi in all 27 EU member states, as well as Iceland, Liechtenstein and Norway.
This follows its approval from the FDA in October.
Pfizer's Executive VP and Chief International Commercial Officer, Alexandre de Germay, commented: “HYMPAVZI offers a first-in-class treatment option for people living with hemophilia, 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 than four-decade commitment to improve the standard of care in hemophilia, and we look forward to delivering this medicine that reduced bleeds as compared to factor prophylaxis and, importantly, requires limited preparation, meeting a key need for eligible patients.”
“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 D. Laurent Frenzel, Head of the Hemophilia Treatment and Research Center at the Necker-Enfants malades Hospital (Paris Cité).
“HYMPAVZI is a significant advancement for eligible patients in that it may provide bleed prevention as well as once-weekly subcutaneous administration via a pre-filled pen.”