#USA #FDA #Paramus #hemostasis #Fibryga

FDA Enhances Fibrinogen Treatment Options with New Fibryga® Presentation

In a significant move to enhance patient care, Octapharma USA, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new 2-gram presentation of Fibryga® (Fibrinogen [Human] Lyophilized Powder for Reconstitution). This latest approval provides a pivotal tool for healthcare providers treating Acquired Fibrinogen Deficiency (AFD), crucial during emergency situations.

Increased Accessibility for Clinicians

The newly introduced kit comprises a 2-gram single-dose bottle, complementing the previously available 1-gram version. This innovation brings enhanced dosing options and simplifies reconstitution, a critical need during urgent medical events such as uncontrolled bleeding. The 2-gram kit includes 100 mL of Water for Infusion (WFI) and utilizes the nextaro® reconstitution device, both designed to streamline the preparation process, allowing clinicians to respond swiftly in life-threatening episodes.

Flemming Nielsen, President of Octapharma USA, emphasized the necessity of this advancement: “The introduction of the 2-gram Fibryga® kit is a direct response to the needs of clinicians managing critical bleeding.” This assertion underlines the importance of swift and accurate action when life hangs in the balance.

A Paradigm Shift in Hemostasis

Fibryga® stands out as the first and only virus-inactivated, human plasma-derived fibrinogen concentrate approved in the U.S. for AFD. Its innovative lyophilized powder formulation enables rapid reconstitution at the point of care, presenting a reliable alternative to traditional cryoprecipitate, which has been the longstanding standard despite its inherent limitations.

The new product line follows the success of Fibryga's 2024 FDA approval for AFD, which was supported by the influential FIBRES study published in JAMA. This study determined that fibrinogen concentrate is non-inferior to cryoprecipitate for managing surgical bleeding, highlighting its standardized dosing, quicker preparation time, and reduced viral transmission risks.

Commitment to Patient-Centric Solutions

Octapharma's commitment to improving patient outcomes through innovative solutions is apparent. According to Huub Kreuwel, Ph.D., Vice President of Medical Affairs at Octapharma USA, “The new 2-gram Fibryga® kit is another step forward in our mission to redefine the standard of care in hemostasis.” With this approval, Fibryga® is now deemed suitable for fibrinogen supplementation for both congenital and acquired fibrinogen deficiencies. The products are marketed in both 1-gram and 2-gram kits, both featuring the nextaro® device for efficient reconstitution.

About Fibryga®

Fibryga® is explicitly indicated for fibrinogen supplementation in patients suffering from bleeding due to acquired fibrinogen deficiency and is also utilized for treating acute bleeding episodes in individuals with congenital fibrinogen issues, including afibrinogenemia and hypofibrinogenemia. It is important to note that Fibryga® is not indicated for individuals with dysfibrinogenemia.

Safety Considerations

While Fibryga® has shown considerable potential in emergency medical situations, patients should be monitored for any early signs of hypersensitivity or severe allergic reactions. Notably, there have been instances of thrombotic events in patients treated with Fibryga®. Additionally, other serious adverse reactions may occur, including thromboembolic episodes and anaphylactic responses. Common reactions documented during clinical trials include abnormalities in hepatic function, acute kidney injury, and anemia among others.

For complete prescribing information, healthcare professionals should refer to fibrygausa.com/pi. For further insights about Fibryga®, visit fibrygausa.com.

About Octapharma

Octapharma is a global leader in the development and production of human protein therapies. With its headquarters in Lachen, Switzerland, and operations spanning across 120 countries, Octapharma employs over 11,000 people dedicated to excellence in Immunotherapy, Hematology, and Critical Care. With a history of over 40 years, the organization focuses on improving lives through quality, innovation, and a commitment to patient care. Learn more about Octapharma at octapharma.com.