Octapharma USA, Inc. announced that the U.S. Food and Drug Administration has approved a new 2-gram version of Fibryga, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for patients with acquired fibrinogen deficiency. The updated kit comes with 100 milliliters of Water for Infusion and continues to include the nextaro reconstitution device, designed to make preparation easier and more flexible for healthcare professionals.
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This new 2-gram single-dose option complements the existing 1-gram Fibryga kit, providing clinicians with more choices for rapid dosing and reconstitution in urgent bleeding situations. The addition reflects Octapharma’s commitment to improving patient care through innovative product development and clinical excellence in the use of factor concentrates.
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Flemming Nielsen, President of Octapharma USA, explained that the new 2-gram kit was created in response to the needs of healthcare providers managing critical bleeding. He noted that by simplifying preparation and giving more dosing flexibility, the kit allows clinicians to act more quickly and accurately when every minute matters.
Fibryga is the first and only virus-inactivated, human plasma-derived fibrinogen concentrate approved for acquired fibrinogen deficiency in the United States. Its lyophilized powder format allows rapid reconstitution at the point of care, offering a reliable and precise alternative to cryoprecipitate, which has traditionally been used but carries variability in dosing and a higher risk of viral transmission.
The expanded Fibryga line builds on the product’s 2024 FDA approval for acquired fibrinogen deficiency, which was supported by the FIBRES study published in JAMA. The research demonstrated that fibrinogen concentrate is as effective as cryoprecipitate in controlling surgical bleeding, while providing standardized dosing, faster preparation, and reduced infection risk.
Huub Kreuwel, Ph.D., Vice President of Medical Affairs at Octapharma USA, emphasized that the new 2-gram Fibryga kit represents a continued investment in innovations that improve outcomes for patients with serious bleeding complications. He added that this advancement helps Octapharma further its mission of improving standards of care in hemostasis.
Fibryga is now approved in the United States for fibrinogen supplementation in both congenital and acquired deficiencies. It is available in 1-gram and 2-gram kits, each equipped with the nextaro® reconstitution device for efficient preparation.
Fibryga is indicated for fibrinogen supplementation in bleeding patients with acquired fibrinogen deficiency and for treating acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. It is not approved for use in patients with dysfibrinogenemia.
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