FDA Approves New 2-Gram Presentation of Fibryga®, Enhancing Convenience and Precision in Treating Acquired Fibrinogen Deficiency

PARAMUS, N.J., Jan. 7, 2026 /PRNewswire/ -- Octapharma USA, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new 2-gram presentation of Fibryga^®, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for fibrinogen replacement in patients with acquired fibrinogen deficiency (AFD). This new kit includes 100 mL of Water for Infusion (WFI) and continues to feature the nextaro^® reconstitution device, offering enhanced convenience and flexibility for healthcare providers.

The 2-gram single-dose bottle joins the existing 1-gram version, giving clinicians more options for streamlined dosing and reconstitution in urgent bleeding scenarios. This innovation reflects Octapharma's ongoing commitment to advancing patient care through insightful product development and clinical excellence in the use of factor concentrates.

"The introduction of the 2-gram Fibryga^® kit is a direct response to the needs of clinicians managing critical bleeding," said Flemming Nielsen, President, Octapharma USA. "By simplifying preparation and expanding dosing flexibility, we're helping providers act faster and more precisely – when every second counts."

Fibryga^® is the first and only virus-inactivated, human plasma-derived fibrinogen concentrate approved for AFD in the U.S. The product's lyophilized powder formulation allows for rapid reconstitution at the point of care, offering a more consistent and targeted alternative to cryoprecipitate, which has long been the standard of care despite its limitations.

The expanded product line builds on the success of Fibryga's 2024 FDA approval for AFD, which was supported by the landmark FIBRES study published in JAMA. The study demonstrated that fibrinogen concentrate is non-inferior to cryoprecipitate in managing bleeding during surgery, with the added benefits of standardized dosing, faster preparation, and reduced risk of viral transmission.

"Octapharma continues to invest in innovations that improve outcomes for patients with serious bleeding complications," said Huub Kreuwel, Ph.D., Vice President of Medical Affairs,Octapharma USA. "The new 2-gram Fibryga^® kit is another step forward in our mission to redefine the standard of care in hemostasis."

Fibryga^® is now approved in the U.S. for fibrinogen supplementation in both congenital and acquired fibrinogen deficiency, and is available in 1-gram and 2-gram kits, each with the nextaro^® device for efficient reconstitution.

About Fibryga^®
Fibryga^® is a human fibrinogen concentrate indicated for: fibrinogen supplementation in bleeding patients with acquired fibrinogen deficiency; and treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Fibryga^® is not indicated for dysfibrinogenemia.

Contraindications
Anaphylactic or severe reactions to Fibryga^® or its components (Sodium Citrate Dihydrate; Glycine; L-Arginine Hydrochloride).

Warnings and Precautions
Monitor patients for early signs of hypersensitivity or allergic reactions. If necessary, discontinue administration and institute appropriate treatment.

Thrombotic events have been reported in patients receiving Fibryga^®. Treatment with human fibrinogen concentrate in congenital fibrinogen deficiency has been associated with thrombosis at target plasma fibrinogen levels that were below 150 mg/dL. The thrombotic risks may be greater when the target fibrinogen plasma level is 150 mg/dL. Weigh the benefits of administration versus the risks of thrombosis.

Fibryga^® is made from pooled human plasma. Products made from human plasma may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Adverse Reactions
The most serious adverse reactions that may be observed with Fibryga^® are thromboembolic episodes and anaphylactic-type reactions. The most common adverse reactions observed in clinical studies with Fibryga^® in acquired fibrinogen deficiency (> 5% of patients) were abnormal hepatic function, acute kidney injury, anemia, atrial fibrillation, delirium and renal failure.

The most common adverse reactions observed in clinical studies with Fibryga^® in congenital fibrinogen deficiency (> 5% of patients) were nausea, vomiting, pyrexia (fever), and thrombocytosis.

For full prescribing information, please visit fibrygausa.com/pi. For more information on Fibryga^®, please visit fibrygausa.com,

Nextaro^® is a registered trademark of sfm medical devices GmbH.

About Octapharma
Octapharma is one of the world's largest human protein manufacturers, developing and producing therapies from human plasma and human cell lines. Headquartered in Lachen, Switzerland, Octapharma has over 11,000 employees and serves patients in 120 countries across Immunotherapy, Hematology, and Critical Care.

With seven R&D sites, five manufacturing facilities in Europe, and more than 195 plasma donation centers in the U.S. and Europe, Octapharma has delivered trusted therapies for over 40 years. The company is committed to improving lives through innovation, quality, and a deep focus on patient care and clinical partnership. To learn more please visit www.octapharma.com.

FIBR-0378

SOURCE Octapharma