MedPath

Fibrinogen human

Generic Name
Fibrinogen human
Brand Names
Artiss, Evarrest, Evicel, Fibryga, Riastap, Tachosil, Tisseel, Vistaseal
Drug Type
Biotech
CAS Number
9001-32-5
Unique Ingredient Identifier
N94833051K
Background

Fibrinogen concentrate (human) is a hematological agent. It works by replacing a certain protein in the blood that helps with blood clotting. Fibrinogen (factor I) is a soluble plasma glycoprotein with a molecular weight of about 340 kDa. It is a physiological substrate for three enzymes: plasmin, factor XIIIa and thrombin. It is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Indication

Human fibrinogen is used for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

In combination with thrombin, it is used indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.

Associated Conditions
Bleeding, Dura Mater Nick Cut or Tear, Surgical Bleeding, Acute bleeding episodes
Associated Therapies
Tissue Adhesions, Maintenance of surgical hemostasis therapy
Clinical Trials
Related News

Biotest Reports 6% Sales Growth in 2024, FDA Approves Yimmugo for US Market

• Biotest AG achieved €726.2 million in sales for 2024, a 6.1% increase driven primarily by strong performance of Intratect and Yimmugo, with EBIT reaching €94.5 million at the upper end of forecast range. • The FDA approved Yimmugo in June 2024 and certified Biotest's production facility, enabling the company to secure a long-term distribution agreement with Kedrion Biopharma expected to generate over $1 billion in the next seven years. • Biotest successfully completed the AdFirst Phase III trial and submitted marketing authorization applications for its new fibrinogen preparation in key European markets and to the FDA, with approval decisions expected by the end of 2025.

Biotest Submits Fibrinogen Biologics License Application to FDA

• Biotest has submitted a Biologics License Application (BLA) to the FDA for its Fibrinogen product, addressing acquired fibrinogen deficiency. • The application includes treatment and prophylaxis of acute bleeding episodes in patients with congenital fibrinogen deficiency, expanding its potential use. • Clinical data supports the efficacy and safety of Biotest's Fibrinogen, offering advantages over current treatments like fresh frozen plasma. • The FDA is expected to make a decision by the end of 2025, following a similar application submitted in Europe in October 2024.

Grifols' VISTASEAL Receives FDA Approval for Pediatric Surgical Bleeding

• Grifols' fibrin sealant (FS), VISTASEAL, gains FDA approval for controlling surgical bleeding in pediatric patients, expanding its availability in the U.S. • The approval is based on a Phase 3b study demonstrating over 95% efficacy in achieving hemostasis within four minutes in pediatric patients. • VISTASEAL combines human fibrinogen and thrombin, applied using Johnson & Johnson MedTech's airless spray technology to rapidly form clots. • Disruptive bleeding occurs in one-third to two-thirds of open surgeries, making VISTASEAL a crucial adjunct when standard techniques are insufficient.

FDA Approves VISTASEAL Fibrin Sealant for Pediatric Surgical Bleeding

• The FDA has approved VISTASEAL, a fibrin sealant from Grifols, for controlling surgical bleeding in pediatric patients. • VISTASEAL combines fibrinogen and thrombin proteins to promote hemostasis and tissue sealing during surgery, reducing blood loss. • A Phase 3b study demonstrated VISTASEAL's efficacy in achieving hemostasis within 4 minutes in over 95% of pediatric patients. • VISTASEAL is contraindicated for intravascular injection or use in patients with anaphylaxis to human blood products.

Fibrinogen-to-Albumin Ratio Predicts Preeclampsia Risk in Laboring Women

• A new study reveals that the fibrinogen-to-albumin ratio (FAR) can predict preeclampsia risk in women upon hospital admission for labor. • Women with an elevated FAR, specifically above 0.1, showed a 24% increased risk, while those above 0.3 had over a 41% increased risk of preeclampsia. • The FAR assessment could provide anesthesiologists and obstetricians with a valuable tool for early identification and management of preeclampsia risks. • Further research is needed to establish a universally accepted FAR range for preeclampsia prediction and its integration into routine prenatal care.

September 2024: FDA Actions Span Diabetes, Neurology, and Rare Diseases

• The FDA approved Embecta's tubeless patch pump for insulin delivery in adults with type 1 and type 2 diabetes, offering a 300-unit reservoir based on patient feedback. • Sparsentan (Filspari) received full FDA approval to slow kidney function decline in adults with primary IgA nephropathy (IgAN), based on positive Phase 3 PROTECT study data. • Approvals for arimoclomol (Miplyffa) and levacetylleucine (Aqneursa) mark the first specific treatments for neurological symptoms of Niemann-Pick disease type C (NPC). • Dupilumab (Dupixent) gained approval for COPD, chronic rhinosinusitis with nasal polyps, and was submitted for label expansion for adult growth hormone deficiency.
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy