Hympavzi FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 16, 2024.
FDA Approved: Yes (First approved October 11, 2024)
Brand name: Hympavzi
Generic name: marstacimab-hncq
Dosage form: Injection
Company: Pfizer Inc.
Treatment for: Hemophilia A, Hemophilia B
Hympavzi (marstacimab-hncq) is a tissue factor pathway inhibitor (TFPI) antagonist used for the treatment of adults and adolescents with hemophilia A or B without inhibitors.
- Hympavzi is 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 (congenital factor VIII deficiency) without factor VIII inhibitors, or
- hemophilia B (congenital factor IX deficiency) without factor IX inhibitors. - Hemophilia is a family of rare genetic blood diseases caused by a clotting factor deficiency (FVIII in hemophilia A, FIX in hemophilia B), which prevents normal blood clotting, resulting in episodes of bleeding. The most common treatment approach for hemophilia A and B is factor replacement therapy, which replaces the missing clotting factors, but approximately 25-30% of people with hemophilia A and 3-5% of people with hemophilia B are unable to continue taking factor replacement therapies because they develop inhibitors to FVIII and FIX.
- Hympavzi contains marstacimab-hncq, a human monoclonal immunoglobulin G isotype, subclass 1 (IgG1) that works as a prophylactic treatment in individuals with hemophilia A or hemophilia B without inhibitors by targeting the Kunitz 2 domain of tissue factor pathway inhibitor (TFPI), a natural anticoagulation protein that functions to prevent the formation of blood clots.
- FDA approval was based on results from the BASIS study which showed that Hympavzi reduced the annualized bleeding rate (ABR) for treated bleeds by 35% and 92% after a 12-month active treatment period compared to routine prophylaxis (RP) and on-demand (OD) treatment, respectively, in patients with hemophilia A or B without inhibitors.
- Hympavzi is administered by subcutaneous injection once weekly.
- Warnings and precautions associated with Hympavzi include thromboembolic events, hypersensitivity reactions, and embryofetal toxicity.
- Adverse reactions include injection site reaction, headache, and pruritus.
Development timeline for Hympavzi
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.