FDA Approves Additional Indication for Fibryga® for Fibrinogen Supplementation in Bleeding Patients with Acquired Fibrinogen Deficiency, Potentially Ushering in a New Standard of Care
PR Newswire
6 min read
PARAMUS, N.J, Aug. 1, 2024 /PRNewswire/ -- Octapharma USA, Inc. has announced the expanded approval of fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD) by the U.S. Food and Drug Administration (FDA). As the first and only on-demand, virus-inactivated, human plasma-derived fibrinogen concentrate option with this approval, fibryga represents a rapid and more precise option for severe bleeding scenarios than the current standard of care (cryoprecipitate).
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Fibrinogen plays an important role in coagulation and blood clotting in emergency and surgical settings. Fibrinogen is the first coagulation factor to drop to critically low levels during severe bleeding episodes. Rapid replenishment of fibrinogen is essential for achieving hemostasis in bleeding patients. Acquired fibrinogen deficiency (AFD) often results from severe bleeding and can impair blood clot formation, increasing the risk of ongoing hemorrhage in patients. Cryoprecipitate, which was introduced in 1964, comes with significant drawbacks, including long thawing and preparation processes, variable levels of fibrinogen, inclusion of additional coagulation-dependent components, and a higher risk of viral transmission. The approval of fibryga for AFD is a major advancement from the current standard of care. As a lyophilized powder, it can be stored at room temperature or refrigerated and can be quickly reconstituted at the point of patient care. It's precise and delivers a highly purified and consistent amount of fibrinogen for accurate treatment.
"In the surgical theater, time matters. And confidence matters. This expanded FDA approval of fibryga represents a major step forward in our commitment to redefining the standard of care for patients experiencing major bleeding. It provides an important option for providers who must act urgently," said Flemming Nielsen, President, Octapharma USA, Inc. "We are proud to be the first to offer this therapeutic advancement—and a new standard of care—to hospitals, anesthesiologists, surgeons, OB/GYNs, and patients across the United States."
The expanded FDA approval of fibryga was based on the FIBRES [FIBrinogen REplenishment in Surgery] study published in JAMA, which was a head-to-head, multicenter, randomized clinical trial in 735 patients, demonstrating that fibrinogen concentrate was non-inferior to cryoprecipitate and may be used instead of cryoprecipitate for the treatment of bleeding related to AFD. Fibryga has already received regulatory approval for the treatment of AFD in both the European Union in 2019 and Canada in 2020.
Today's approval marks the third FDA approval received to date for fibryga. In 2017, the FDA granted an approval for acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. A second was received in 2020 for pediatric patients under 12 years for treatment of acute bleeding episodes in congenital fibrinogen deficiency.
"The recent FDA approval is the result of years of dedicated research and development in fibrinogen replacement," commented Huub Kreuwel, Ph.D., VP of Medical Affairs at Octapharma USA, Inc. "Fibryga's expanded indication will allow practitioners and health systems to support a broader range of patients with serious bleeding complications who require fibrinogen replacement therapy."
The medical community has welcomed this approval as a significant advancement in patient care for those with AFD. "This first-in-class FDA approval for fibryga, a fibrinogen concentrate with an expanded indication to treat bleeding patients urgently in need of fibrinogen replacement, is an important step toward improving patient safety and outcomes. Compared to cryoprecipitate, fibrinogen concentrate allows for targeted dosing and faster treatment of low fibrinogen in maternal hemorrhage," states John Kowalczyk, MD, and Michaela Farber, MD, MS, Division of Obstetric Anesthesia, Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Octapharma is committed to working closely with healthcare providers and patient organizations to ensure broad access to fibryga for those who can benefit from it.
Indications and Important Safety Information for fibryga Indications and Usage Fibryga is a human fibrinogen concentrate indicated for fibrinogen supplementation in bleeding patients with acquired fibrinogen deficiency and in treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
Fibryga is not indicated for dysfibrinogenemia.
Contraindications Fibryga is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis, 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 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 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.
About Octapharma and Octapharma USA Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.
Octapharma employs nearly 12,000 employees worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Hematology, and Critical Care.
Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centers across Europe and the US. Octapharma has 40 years of experience in patient care. The company's American subsidiary, Octapharma USA, Inc., is located in Paramus, N.J. For more information, please visit octapharmausa.com.
