Octapharma USA has received approval from the U.S. Food and Drug Administration for a new 2-gram presentation of Fibryga®, a human plasma-derived fibrinogen concentrate, expanding treatment options for patients with acquired fibrinogen deficiency (AFD). The approval marks an important step in enhancing dosing flexibility and speed of care for clinicians managing urgent and life-threatening bleeding situations.
The newly approved 2-gram single-dose kit includes 100 mL of Water for Infusion and continues to feature Octapharma’s nextaro® reconstitution device, which is designed to simplify and accelerate preparation at the point of care. The new presentation complements the existing 1-gram Fibryga® kit, allowing healthcare providers to tailor dosing more efficiently based on patient needs and the severity of bleeding, particularly in emergency or surgical settings.
Flemming Nielsen, President of Octapharma USA, said the new presentation directly addresses real-world clinical demands. He noted that managing critical bleeding often requires rapid and precise intervention, and the 2-gram kit helps clinicians prepare treatment more quickly while reducing the need for multiple vials. According to the company, this streamlined approach can be especially valuable when time is critical and treatment decisions must be made quickly.
Fibryga® holds a unique position in the U.S. market as the first and only virus-inactivated, human plasma-derived fibrinogen concentrate approved for the treatment of acquired fibrinogen deficiency. Its lyophilized powder formulation enables rapid reconstitution, offering a more consistent and targeted alternative to cryoprecipitate, which has historically been the standard of care despite challenges such as variable fibrinogen content, longer preparation times, and potential safety concerns.
The expanded product offering builds on Fibryga®’s FDA approval in 2024 for AFD, which was supported by data from the landmark FIBRES study published in JAMA. The study demonstrated that fibrinogen concentrate was non-inferior to cryoprecipitate in controlling bleeding during surgery, while also providing advantages such as standardized dosing, faster availability, and a lower risk of viral transmission.
Huub Kreuwel, Ph.D., Vice President of Medical Affairs at Octapharma USA, said the company remains focused on advancing hemostasis care through innovation. He emphasized that the new 2-gram kit represents another step toward redefining the standard of care for patients experiencing serious bleeding complications.
With this latest approval, Fibryga® is now authorized in the U.S. for fibrinogen supplementation in both congenital and acquired fibrinogen deficiency. The product is available in 1-gram and 2-gram kits, each incorporating the nextaro® device, reinforcing Octapharma’s commitment to improving clinical efficiency and patient outcomes in critical care settings.