Pfizer has received the European Commission’s (EC) marketing authorisation for expanding the approved Hympavzi (marstacimab) indication to treat haemophilia A or B with inhibitors in patients aged 12 years and above.

The approval covers adults and adolescents in the European Union (EU) who weigh at least 35kg and have haemophilia A (factor VIII deficiency) with factor VIII inhibitors, or haemophilia B (factor IX deficiency) with factor IX inhibitors.

It includes all 27 EU member states, Liechtenstein, Norway, and Iceland.

Hympavzi is administered as a once-weekly subcutaneous injection and does not require routine treatment-related laboratory monitoring for this inhibitor patient population.

Its approval is based on Phase III BASIS trial data showing Hympavzi treatment achieved a 93% reduction in mean treated annualised bleeding rate compared to on-demand therapy.

The trial also demonstrated sustained efficacy and safety over up to 53 months of treatment.

The most common adverse events were injection site reactions, headache, pruritus, hypertension, and rash. Thrombosis was reported as the most serious adverse event.

Separately, the US Food and Drug Administration has granted priority review for Hympavzi’s supplemental biologics license application to extend its indication to patients aged six years and older with haemophilia A or B with inhibitors.

A decision is expected by the second quarter of 2026.

Pfizer chief international commercial officer and executive vice-president Alexandre de Germay said: “For people living with haemophilia with inhibitors, recurring bleeding episodes can lead to damaged joints and introduce real limitations and disruptions to everyday life.

“This approval brings a once-weekly medicine to the EU that meets a critical need for patients who face a treatment journey that can be complex and challenging with limited options available today, representing the latest step in Pfizer’s more than 40-year commitment to advancing care for people living with haemophilia.”

Last month, Pfizer and Astellas received acceptance from the US Food and Drug Administration for priority review of their supplemental biologics licence application (sBLA) for perioperative Padcev (enfortumab vedotin-ejfv) combined with the PD-1 inhibitor Keytruda (pembrolizumab) for muscle-invasive bladder cancer (MIBC).