On January 8, 2026, the U.S. Food and Drug Administration (FDA) granted approval for a new 2-gram (g) formulation of Fibryga, a human plasma-derived fibrinogen concentrate. This therapy is specifically designed for fibrinogen supplementation in patients suffering from Acquired Fibrinogen Deficiency (AFD).
Enhancements for critical care The introduction of the 2g dosage alongside the existing 1g version provides healthcare providers with greater clinical flexibility. Key features of the new kit include:
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Streamlined Preparation: The kit contains 100ml Water for Infusion and the Nextaro reconstitution device, enabling faster medication setup during life-threatening bleeding episodes.
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Alternative to Traditional Therapy: As the only virus-inactivated fibrinogen concentrate approved for AFD in the U.S., Fibryga serves as a consistent alternative to cryoprecipitate, which often faces challenges regarding thawing time and standardized dosing.
Scientific foundation and indications The approval is supported by the FIBRES study, which demonstrated the non-inferiority of fibrinogen concentrate compared to cryoprecipitate in surgical settings. Beyond AFD, Fibryga is also authorized for managing acute bleeding in patients with congenital fibrinogen deficiency. Octapharma officials stated that this new formulation allows clinicians to act with greater speed and precision in emergency scenarios where “every second counts.”
Source: https://www.pharmaceutical-technology.com/news/octapharma-fda-approval-fibryga-formulation/?cf-view