By Don Tracy, Associate Editor

Expanded indication makes Fibryga the first and only on-demand, virus-inactivated, human plasma-derived fibrinogen concentrate approved for this indication.The FDA has approved an expanded indication for Octapharma’s Fibryga, a lyophilized human fibrinogen concentrate now indicated for patients experiencing bleeding due to acquired fibrinogen deficiency (AFD). According to the company, this approval marks a significant advancement over cryoprecipitate, the current standard of care, by providing a faster and more precise treatment option for severe bleeding episodes. Additionally, the regulatory action makes Fibryga the first and only on-demand, virus-inactivated, human plasma-derived fibrinogen concentrate approved for this indication.1
"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, in a press release. "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 approval was based on results from the FIBRES study, a head-to-head, multicenter, randomized clinical trial that included 735 patients. Results found that fibrinogen concentrate was non-inferior to cryoprecipitate and may be used instead of cryoprecipitate for the treatment of bleeding related to AFD. Previously, the drug was approved for the treatment of AFD in the European Union in 2019 and Canada in 2020.
Common adverse events (AEs) in studies of Fibryga in AFD included abnormal hepatic function, acute kidney injury, anemia, atrial fibrillation, delirium, and renal failure. Common AEs in congenital fibrinogen deficiency were nausea, vomiting, pyrexia (fever), and thrombocytosis. The most serious AEs included thromboembolic episodes and anaphylactic-type reactions.1
"The recent FDA approval is the result of years of dedicated research and development in fibrinogen replacement," commented Huub Kreuwel, PhD, VP, medical affairs, Octapharma, in the press release. "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."
Octapharma has warned that Fibryga can cause allergic reactions or hypersensitivity, suggesting that it could lead to discontinuation. Additionally, Fibryga consists of pooled human plasma, which may contain infectious agents, viruses, and, theoretically, the Creutzfeldt-Jakob disease agent.1
Globally, approximately every one in a million people face fibrinogen deficiency. It is considered life-threating and is defined as a quantitative efficiency characterized by a complete absence or extremely low levels of fibrinogen.2
"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," said 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, in the press release.
Previously, the FDA granted approval for acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia in 2017. In 2020, it received a second approval for pediatric patients under 12 years of age for the treatment of acute bleeding episodes in congenital fibrinogen deficiency.1