Pfizer’s HYMPAVZI Receives FDA Approval for Hemophilia A and B Treatment

FDA Approval:
The U.S. Food and Drug Administration (FDA) has approved Pfizer's HYMPAVZI (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 12 years of age and older with hemophilia A or B without inhibitors.

Treatment Mechanism:
HYMPAVZI is an anti-tissue factor pathway inhibitor (anti-TFPI) that works by reducing the activity of TFPI, a natural anticoagulation protein, thereby increasing thrombin generation and promoting blood clotting.

Administration:
HYMPAVZI is administered subcutaneously once weekly, offering a more convenient alternative to traditional intravenous infusions. It is the first hemophilia medicine approved in the U.S. to be administered via a pre-filled, auto-injector pen.

Clinical Evidence:
The approval is based on the Phase 3 BASIS study, which demonstrated a statistically significant and clinically relevant reduction in annualized bleeding rate (ABR) compared to the current standard-of-care treatment for hemophilia patients.

Market Position:
HYMPAVZI is Pfizer's second hemophilia treatment to receive FDA approval this year, following the approval of Beqvez (fidanacogene elaparvovec) for hemophilia B in April 2024.

Cost and Coverage:
HYMPAVZI has a wholesale acquisition cost (WAC) of $795,600 and is positioned as a cost-effective option compared to other treatments on the market.

Regulatory Status:
A regulatory filing for HYMPAVZI is currently under review in the EU, seeking approval for the same indication.