Biotest Submits Fibrinogen Biologics License Application to FDA
Key Insights
Biotest has submitted a Biologics License Application (BLA) to the FDA for its Fibrinogen product, addressing acquired fibrinogen deficiency (search).
The application includes treatment and prophylaxis of acute bleeding episodes in patients with congenital fibrinogen deficiency (search), expanding its potential use.
Clinical data supports the efficacy and safety of Biotest's Fibrinogen, offering advantages over current treatments like fresh frozen plasma.
Biotest AG has announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its Fibrinogen product. This application marks a significant step toward addressing the unmet medical need for additional fibrinogen in patients with acquired fibrinogen deficiency (search), as well as for the treatment and prophylaxis of acute bleeding episodes in patients with congenital fibrinogen deficiency.
The FDA is currently evaluating the application, with a decision anticipated by the end of 2025. This submission follows Biotest's earlier application for marketing authorization in selected European markets, filed in October 2024.
Clinical Efficacy and Safety
According to Dr. Christina Erb, Head of Scientific Operations and Innovation, "Clinical data demonstrates efficacy and safety of Biotest's Fibrinogen in various bleeding conditions." Fibrinogen deficiency (search) can lead to uncontrolled blood loss, potentially resulting in patient mortality. Biotest's Fibrinogen offers the advantage of room temperature storage and a design for more convenient and faster preparation compared to alternatives, providing an effective and safe option for managing bleeding in patients with serious and potentially life-threatening conditions.
Advantages Over Current Treatments
In many regions, cryoprecipitate or fresh frozen plasma (FFP) are standard treatments for major surgical bleeding. However, these contain additional proteins and components that may have undesired effects. Biotest's Fibrinogen undergoes rigorous pathogen safety protocols and offers the benefits of being readily available and allowing for faster administration, ensuring timely and targeted treatment.
About Biotest's Fibrinogen
The newly developed manufacturing process for fibrinogen results in high-purity fibrinogen with a defined concentration, high level of viral safety, and good solubility.
AdFIrst Trial Details
The AdFIrst trial (no. 995) was a prospective, active-controlled, multicentre phase III trial assessing the efficacy and safety of Fibrinogen (BT524) in patients with acquired fibrinogen deficiency (search). Patients experiencing high blood loss during planned spinal or abdominal surgery were randomized 1:1 to treatment with Fibrinogen (BT524) or fresh frozen plasma (FFP)/cryoprecipitate. The trial compared blood loss between the two treatment options to evaluate the efficacy of BT524. Full trial results are expected to be published in a medical journal later in 2025.
About Fibrinogen and its Deficiency
Fibrinogen, produced in the liver, is a key blood clotting factor involved in primary haemostasis and wound healing. A deficiency impairs blood's ability to clot, increasing the risk of bleeding and delayed haemostasis. Unlike FFP and cryoprecipitate, which contain variable amounts of fibrinogen and require thawing, Biotest's product provides a defined amount for tailored, effective treatment.