FDA Extends Approval of Fibryga to Include Bleeding Patients With Acquired Fibrinogen Deficiency
This is the first and only on-demand, virus-inactivated, human plasma-derived concentration option that is indicated for this approval.
The FDA approved an expanded indication for fibrinogen (human) lyophilized powder for reconstitution (Fibryga; Octapharma USA Inc) for the replacement of fibrinogen in bleeding patients with acquired fibrinogen deficiency. This is the first and only on-demand, virus-inactivated, human plasma-derived concentration option.1
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"In the surgical theater, time matters, and confidence matters. This expanded FDA approval of fibrinogen 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 of Octapharma USA Inc, in a news release. "We are proud to be the first to offer this therapeutic advancement—and a new standard of care—to hospitals, anesthesiologists, surgeons, [obstetrics and gynecology], and patients across the United States."1
Fibrinogen helps with coagulation and blood clotting in emergency and surgical settings, according to the news release. It can also help to drop critically low levels during bleeding episodes. This approval is a major advancement for AFD, especially because the formulation can be stored at room temperature or refrigerated and can be quickly reconstituted at the point of care for patients. The indications also included treatment of bleeding episodes for patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia, according to the FDA. It is not indicated for dysfibrinogenemia.1,2
The expanded approval was based on data from the FIBRES (NCT03037424) clinical trial. Investigators included adults who were undergoing cardiac surgery with cardiopulmonary bypass who needed fibrinogen replacement due to clinically significant bleeding, according to the study authors. Bleeds were related to acquired hypofibrinogenemia. Treatment was assigned 1:1 with patients receiving either fibrinogen concentrate of 4 g fibrinogen infused over approximately 10 minutes or 10 unites of cryoprecipitate.3
The primary outcome included cumulative allogeneic blood component units—made up of red blood cells, platelets, and plasma—administered for 24 hours after cardiopulmonary bypass. Secondary outcomes included individual blood component united administered 24 hours post-bypass, all transfusion beginning at the start of surgery to postoperative day 7, bleeding severity 24 hours after bypass, and pretreatment and post treatment fibrinogen levels. Adverse events (AEs) were also recorded.3
Patients were included from February 10, 2017, to November 1, 2018, including 735 individuals in the primary analysis—372 for fibrinogen concentrate and 363 for cryoprecipitate. The trial concluded early based on recommendations of the independent data and safety monitoring committee, according to the study authors.3
For the primary analysis, mean allogenic blood component units administered were 16.7 units within 24 hours after the bypass and 22.4 from beginning of surgery to postoperative day 7. The mean 24-hour post-bypass was 16.3 units for fibrinogen and 17 units for cryoprecipitate. For the secondary outcomes of individual 24-hour and cumulative 7-day transfusion, investigators observed noninferiority comparing the 2 treatments.3
Treatment-emergent AEs were similar, with 35 deaths in the fibrinogen group and 27 in the cryoprecipitate group. Thromboembolic AEs were observed in 26 patients and 35 patients, respectively.3
