Comments Off On Pfizer’s Hympavzi Approved By FDA For Use In Treating Hemophilia Symptoms

HYMPAVZI is the first and only anti-tissue factor pathway inhibitor (anti-TFPI) approved in the U.S. for the treatment of hemophilia A or B and the first hemophilia medicine approved in the U.S. to be administered via a pre-filled, auto-injector pen.

HYMPAVZI can offer a subcutaneous treatment option with a once-weekly dosing schedule and minimal preparation required for each individual administration.

About Hympavzi (Marstacimab-Hncq)

Discovered by Pfizer scientists, HYMPAVZI is a rebalancing agent that targets the Kunitz 2 domain of tissue factor pathway inhibitor (TFPI), a natural anticoagulation protein that functions to prevent the formation of blood clots and restore hemostasis.

HYMPAVZI is approved in the U.S. 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 (congenital factor VIII deficiency) without factor VIII inhibitors, or hemophilia B (congenital factor IX deficiency) without factor IX inhibitors.

About The BASIS Study

The pivotal BASIS study is a global Phase 3, open-label, multicenter study to evaluate the efficacy and safety of HYMPAVZI in adolescent and adult participants ages 12 to <75 years with severe hemophilia A (defined as FVIII <1%) or moderately severe to severe hemophilia B (defined as FIX activity ≤2%) with or without inhibitors.

The FDA approval is based on results from the BASIS study that included 116 people living with hemophilia without inhibitors who were treated with HYMPAVZI during a 12-month active treatment period (ATP) versus an RP and OD intravenous regimen with FVIII or FIX, administered as part of usual care in a six-month observational period.

During the ATP, participants received prophylaxis (a 300 mg subcutaneous loading dose of HYMPAVZI, followed by 150 mg subcutaneously once weekly) with potential for dose escalation to 300 mg once weekly.

Before Using HYMPAVZI, Matters requiring Attention

• have a planned surgery. Your healthcare provider may stop treatment with HYMPAVZI before your surgery. Talk to your healthcare provider about when to stop using HYMPAVZI and when to start it again if you have a planned surgery.
• have a severe short-term (acute) illness such as an infection or injury.
• are pregnant or plan to become pregnant. HYMPAVZI may harm your unborn baby.

Females who are able to become pregnant:

are breastfeeding or plan to breastfeed. It is not known if HYMPAVZI passes into your breast milk.

Your healthcare provider will do a pregnancy test before you start your treatment with HYMPAVZI.

You should use effective birth control (contraception) during treatment with HYMPAVZI and for at least 2 months after the last dose of HYMPAVZI.

Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with HYMPAVZI..

About DengYueMed – HK Drug Wholesale Distributor

As a legally compliant drug import and export company, DengYueMed is certified by the pharmacy & poisons board of Hong Kong — you can verify our qualification on their official website.

Our efforts to improve the affordability of Marstacimab-Hncq drug aim to ensure that more patients can benefit from this important medication.

HK DengYue provides detailed medicine information, transparent pricing, and responsive support to ensure a smooth and reliable buying experience.

Feel free to reach out anytime to discuss your needs or ask questions about the medicine. We welcome you to contact us for a consultation.