Coagulation Factor IX Human
- Generic Name
- Coagulation Factor IX Human
- Brand Names
- Alphanine Sd, Balfaxar, Beriplex, Immunine Vh, Kcentra, Octaplex
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 181054-95-5
- Unique Ingredient Identifier
- 6U90Y1795T
- Background
Factor IX (or Christmas factor) is one of the serine proteases of the coagulation system; it belongs to peptidase family S1. Deficiency of this protein causes hemophilia B.
- Indication
Factor IX is used to treat Christmas disease. Factor IX deficiency is treated by injection factor IX produced from human plasma. Tranexamic acid may be of value in patients undergoing surgery who have inherited factor IX deficiency in order to reduce the perioperative risk of bleeding.
- Associated Conditions
- Acquired Coagulation Factor Deficiency, Bleeding caused by Hemophilia B, Major Bleeding, Vitamin K antagonist induced major bleeding
- Associated Therapies
- -
USFDA approves Pfizer's marstacimab-hncq for treatment of hemophilia A or B
FDA approves Pfizer's HYMPAVZI, the first anti-TFPI for hemophilia A or B, administered via a pre-filled auto-injector pen, offering a once-weekly subcutaneous treatment option.
U.S. FDA Approves Pfizer's HYMPAVZI™ (marstacimab-hncq) for the Treatment of Adults ...
FDA approves HYMPAVZI™ for routine prophylaxis in hemophilia A or B without inhibitors, offering a once-weekly subcutaneous treatment with a manageable safety profile and minimal preparation.
U.S. FDA Approves Pfizer's HYMPAVZI™ (marstacimab-hncq) for the Treatment of Adults
U.S. FDA approves Pfizer’s HYMPAVZI™ (marstacimab-hncq) for hemophilia A or B without inhibitors, based on Phase 3 study results showing substantial bleed reduction. HYMPAVZI is the first once-weekly subcutaneous prophylactic treatment for hemophilia B and the first to use a pre-filled pen or syringe for hemophilia A or B.
FDA Approves Marstacimab-hncq (Hympavzi) for Hemophilia A or B Without Inhibitors
The FDA approved Pfizer’s marstacimab-hncq (Hympavzi) for hemophilia A/B without inhibitors, reducing annualized bleeding rates by 35% and 92% compared to routine prophylaxis and on-demand treatment. The drug, administered via a pre-filled auto-injector pen, marks a significant advancement in hemophilia treatment.
FDA Approves Hympavzi (marstacimab-hncq) for the Treatment of Adults and Adolescents with Hemophilia A or B Without Inhibitors
FDA approves Hympavzi (marstacimab-hncq) for hemophilia A or B without inhibitors, offering a once-weekly subcutaneous treatment option.
Hemophilia gene therapy Beqvez reduces bleeds in Phase 3 trial
Beqvez (fidanacogene elaparvovec) gene therapy for hemophilia B results in stable FIX production, reducing bleeding episodes by about three times compared to prophylaxis. A single dose of Beqvez was well-tolerated, with a 71% drop in annual bleeding rates and 92% decrease in FIX consumption. Mean FIX activity at 15 months was 26.9%, though 62% of patients needed glucocorticoids for elevated liver enzymes.
Related Clinical Trials:
Single-Dose Gene Therapy is Potentially Life-Changing for Adults with Hemophilia
Gene therapy for hemophilia B reduces bleeding episodes by 71% after a single infusion, potentially life-changing for patients. Approved by FDA in April 2024, it enables liver production of clotting factor IX, offering a single-dose alternative to ongoing factor IX infusions.
Single-dose gene therapy is potentially life-changing for adults with hemophilia B
Hemophilia B patients experienced a 71% reduction in bleeding episodes post-gene therapy infusion, per a Phase III trial published in the New England Journal of Medicine. The therapy, approved by the FDA in April 2024, enables liver production of clotting factor IX, potentially transforming patients' lives.
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