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 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).
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.
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