MedPath

FDA Approves First Anti-TFPI Antibody and Biparatopic Antibody Therapy

• The FDA has approved the first anti-TFPI antibody for hemophilia A and B, offering a novel approach to managing bleeding disorders. • The approval marks a significant advancement in hemophilia treatment, potentially reducing the need for frequent factor replacement therapies. • The FDA also approved the first biparatopic antibody therapy, representing a new class of biologics with enhanced target binding capabilities.

The U.S. Food and Drug Administration (FDA) has granted approval to the first anti-TFPI (Tissue Factor Pathway Inhibitor) antibody for the treatment of hemophilia A and B. This approval signifies a major advancement in the management of these bleeding disorders, offering a novel mechanism of action compared to traditional factor replacement therapies.
This anti-TFPI antibody works by inhibiting TFPI, a natural anticoagulant, thereby promoting thrombin generation and improving blood clotting in patients with hemophilia. By targeting TFPI, the antibody helps to rebalance the coagulation system, reducing the frequency of bleeding episodes. The approval is based on clinical trial data demonstrating a significant reduction in annualized bleeding rates (ABR) compared to standard of care.
In addition to the anti-TFPI antibody, the FDA has also approved the first biparatopic antibody therapy. Biparatopic antibodies bind to two distinct epitopes on the same target, offering potentially enhanced efficacy and a broader range of therapeutic applications. This innovative approach represents a new class of biologics with the potential to overcome resistance mechanisms and improve treatment outcomes in various diseases.
Further details regarding the specific indications, dosing regimens, and clinical trial data for these newly approved therapies are expected to be released by the respective pharmaceutical companies. These approvals highlight the ongoing innovation in the biopharmaceutical industry and the commitment to developing novel treatments for unmet medical needs.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

FDA Approves Novo Nordisk's Alhemo for Hemophilia A and B with Inhibitors

The FDA has approved Alhemo (concizumab-mtci) as a once-daily prophylactic treatment for hemophilia A and B with inhibitors in patients 12 years and older.
Alhemo, a subcutaneous injection, is the first of its kind for this patient population, offering an alternative to intravenous infusions.

BridgeBio's Attruby Approved for ATTR-CM, Setting Up Competition with Pfizer's Tafamidis

The FDA has approved BridgeBio's Attruby (acoramidis) for transthyretin amyloid cardiomyopathy (ATTR-CM), offering a new treatment option for this progressive disease.
Attruby demonstrated a statistically significant improvement in a composite endpoint of cardiovascular death and hospitalization in a Phase 3 trial.

European Commission Approves Pfizer's Hympavzi for Haemophilia A and B

The European Commission (EC) has approved Pfizer's Hympavzi (marstacimab) for routine prophylaxis of bleeding episodes in haemophilia A and B patients.
Hympavzi is the first anti-tissue factor pathway inhibitor approved in the EU for haemophilia A or B, administered via a pre-filled, auto-injector pen.

EU Approves Pfizer's Hympavzi for Hemophilia A and B

The European Commission has granted marketing authorization for Pfizer's Hympavzi (marstacimab) for hemophilia A and B patients aged 12 and older.
Hympavzi is a once-weekly prophylactic treatment to reduce bleeding episodes in patients without inhibitors to Factor VIII (FVIII) or Factor IX (FIX).

European Commission Approves Pfizer's HYMPAVZI for Hemophilia A and B

The European Commission has granted marketing authorization to Pfizer's HYMPAVZI (marstacimab) for treating hemophilia A and B based on Phase 3 trial results.
HYMPAVZI is the first once-weekly, subcutaneous treatment in the EU for severe hemophilia B and can be administered via a pre-filled, auto-injector pen.

FDA Approves Hympavzi (marstacimab-hncq) as Novel Treatment for Hemophilia A and B

The FDA has approved Hympavzi (marstacimab-hncq), a novel monoclonal antibody, for hemophilia A and B in patients 12 years and older.
Hympavzi offers a new mechanism by reducing tissue factor pathway inhibitor, enhancing thrombin production to facilitate blood clotting.

FDA Approves Pfizer's Hympavzi (marstacimab-hncq) for Hemophilia A and B

The FDA has approved Hympavzi (marstacimab-hncq) for routine prophylaxis to reduce bleeding episodes in hemophilia A and B patients without inhibitors, aged 12 and older.
Hympavzi is the first anti-TFPI therapy approved in the U.S. for hemophilia A or B, offering a once-weekly subcutaneous administration via a pre-filled auto-injector pen.

FDA Approves Hympavzi (marstacimab-hncq) for Hemophilia A and B Treatment

The FDA has approved Hympavzi (marstacimab-hncq) for routine prophylaxis to reduce bleeding episodes in hemophilia A without factor VIII inhibitors and hemophilia B without factor IX inhibitors.
Hympavzi is a novel treatment that targets tissue factor pathway inhibitor, an anticoagulation protein, to enhance thrombin generation and improve blood clotting.

FDA Approves Pfizer's Hympavzi for Hemophilia A and B

The FDA has approved Hympavzi (marstacimab-hncq), a once-weekly subcutaneous injection, for hemophilia A and B to prevent or reduce bleeding episodes.
Hympavzi is the first anti-tissue factor pathway inhibitor (anti-TFPI) approved in the U.S. for hemophilia A or B, offering a new mechanism of action.

FDA Approves Armour's Mononine, the First Monoclonal Antibody-Purified Hemophilia B Therapy

The FDA approved Armour's Mononine on August 20 for preventing and controlling bleeding in Hemophilia B patients with Factor IX deficiency.
Mononine, a Coagulation Factor IX, is the first monoclonal antibody-purified Hemophilia B therapy, priced at $1.04 per unit.

Reference News

[1]
FDA approves first anti-TFPI antibody for haemophilia A and B - Nature
nature.com · Oct 30, 2024

Nature Reviews Drug Discovery (Nat Rev Drug Discov) has online ISSN 1474-1784 and print ISSN 1474-1776.

[2]
FDA approves first biparatopic antibody therapy - Nature
nature.com · Nov 26, 2024

Nature Reviews Drug Discovery (Nat Rev Drug Discov) has online ISSN 1474-1784 and print ISSN 1474-1776.

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy