FDA Approves New Use for Fibryga® in Treating Acquired Fibrinogen Deficiency

PARAMUS, N.J, Aug. 1, 2024  -- Octapharma USA, Inc. has announced that the U.S. Food and Drug Administration (FDA) has expanded the approval of fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for fibrinogen replacement in patients with acquired fibrinogen deficiency (AFD). This makes fibryga the first and only on-demand, virus-inactivated, human plasma-derived fibrinogen concentrate approved for this indication, offering a rapid and precise treatment option for severe bleeding compared to the current standard of care, cryoprecipitate.

Fibrinogen is crucial for blood clotting and coagulation, especially in emergency and surgical situations. During severe bleeding, fibrinogen is the first coagulation factor to reach critically low levels. Quick replenishment is vital for achieving hemostasis in bleeding patients. Acquired fibrinogen deficiency often occurs due to severe bleeding, which can hinder blood clot formation and increase the risk of continuing hemorrhage. Cryoprecipitate, the current standard introduced in 1964, has notable drawbacks, such as lengthy thawing and preparation times, inconsistent fibrinogen levels, inclusion of other coagulation-dependent components, and a higher viral transmission risk. The FDA’s approval of fibryga for AFD represents a significant advancement over cryoprecipitate. As a lyophilized powder, fibryga can be stored at room temperature or refrigerated and can be reconstituted quickly at the point of care, providing a highly purified and consistent dose of fibrinogen for accurate treatment.

"In the surgical theater, time and confidence are critical. The FDA's expanded approval of fibryga marks a substantial step forward in redefining the standard of care for patients experiencing major bleeding. It offers an important option for providers who must act urgently," stated Flemming Nielsen, President of Octapharma USA, Inc. "We are proud to be the first to present this therapeutic advancement and a new standard of care across the United States."

This expanded FDA approval is based on the FIBRES (FIBrinogen REplenishment in Surgery) study published in JAMA. This head-to-head, multicenter, randomized clinical trial involving 735 patients showed that fibrinogen concentrate was non-inferior to cryoprecipitate and could be used as an alternative in treating bleeding related to AFD. Fibryga had previously received regulatory approval for treating AFD in the European Union in 2019 and Canada in 2020.

Today’s approval is fibryga's third FDA approval. In 2017, it was approved for acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. In 2020, a second approval was granted for pediatric patients under 12 years for treating 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 requiring 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 collaborating closely with healthcare providers and patient organizations to ensure broad access to fibryga for those who can benefit from it.

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