Drug Approval | June 09, 2026
FDA expands Pfizer’s HYMPAVZI approval
Broadening access for children & patients with inhibitor-complicated hemophilia
Broadening access for children & patients with inhibitor-complicated hemophilia
The decision marks a significant expansion for Pfizer’s once-weekly injectable therapy
HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors
HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors
HYMPAVZI’s safety profile was generally favorable
HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis
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