Pfizer's Hympavzi Approved for Treatment of Certain Types of Hemophilia -- Update

Published: 2024-10-11 14:35:11 ET PFE

By Josh Beckerman

The Food and Drug Administration approved Pfizer's Hympavzi to prevent or reduce bleeding episodes in patients with certain kinds of hemophilia, the pharmaceutical company said.

The approval is for patients with hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, or hemophilia B (congenital factor IX deficiency) without factor IX inhibitors, Pfizer said Friday.

Hympavzi, also known as marstacimab, can be given subcutaneously every week for routine prophylaxis in patients age 12 and up as an alternative to intravenous infusions that are often administered multiple times a week, Pfizer said.

The FDA said the drug is the first non-factor and once-weekly treatment for hemophilia B. The agency said the approval provides "a new treatment option that is the first of its kind to work by targeting a protein in the blood clotting process."

Last December, Pfizer reported favorable data from a Phase 3 clinical trial evaluating marstacimab in certain patients. The company said the results demonstrated a statistically significant and clinically meaningful effect on annualized bleeding rate.

In April, the FDA approved Pfizer's Beqvez, a one-time gene therapy for certain hemophilia B patients. In July, the company reported favorable Phase 3 study results for hemophilia A gene therapy candidate giroctocogene fitelparvovec.

Write to Josh Beckerman at [email protected]

(END) Dow Jones Newswires

10-11-24 1434ET