…………………….. catching up on FDA approvals
The FDA recently approved a new therapy, Hympavzi (marstacimab-hncq) from Pfizer Inc., indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors.
This approval is yet another, cutting edge development in the hemophilia category in the past of year+. Hympavzi is the first of its kind and works by targeting a protein in the blood clotting process.
For decades, clotting factor products merely replaced clotting factor. Hympavzi works by reducing the amount of tissue factor pathway inhibitor, a naturally occurring anticoagulation protein. As such, it increases the amount of thrombin, an enzyme that is critical in blood clotting. Ultimately this is approach is expected to reduce the frequency of bleeding episodes.
Hympavzi is a once-weekly subcutaneous injection and is supplied in pre-filled auto-injector pens.
CLICK HERE to access prescribing information
Pfizer set a wholesale acquisition cost (WAC) at $795,600 for Hympavzi.
By comparison to other recent hemophilia breakthrough therapies, Pfizer charges $3.5 million for its Beqvez product and matches the price for Hemgenix , a hemophilia B gene therapy.
The company announced that Hympavzi would launch through Orsini Specialty Pharmacy limited distribution.
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FDA Approves New Treatment for Hemophilia A or B
Product is First Non-Factor and Once-Weekly Treatment for Hemophilia B
