<h4 class="h3 h6 h4">FORMA-05 was a prospective, randomised, controlled study designed to assess non-inferiority of fibryga&reg; to cryoprecipitate for the treatment of acquired fibrinogen deficiency (AFD). Data from the study were used to support regulatory approval of a label extension for fibryga&reg; to include treatment of AFD in patients with severe bleeding.&nbsp;&nbsp;</h4>
Over 12 months, FORMA-05 recruited 55 patients who were undergoing cytoreductive surgery to treat Pseudomyxoma peritonei (PMP), a benign but aggressive form of cancer. This surgical procedure is associated with a high risk of severe bleeding and AFD.
Patients who were expected to experience fibrinogen deficiency due to severe bleeding of more than 2 L of blood loss were randomised to one of two treatment arms to receive either cryoprecipitate (n = 22) or fibryga&reg; (n = 21) for the first 24 hours of treatment. After this time both groups received cryoprecipitate for the remainder of treatment.
The primary endpoint of FORMA-05 was overall haemostatic efficacy, assessed using a 4-point scale (excellent, good, moderate, none). Efficacy was assessed both by treating physicians and by an independent data monitoring and endpoint adjudication committee.&nbsp;
Haemostasis was successfully restored in patients in both treatment arms, demonstrating non-inferiority of fibryga&reg; to cryoprecipitate. Levels of clot-stabilising Factor XIII remained at similar plasma levels in both treatment arms. However, patients in the fibryga&reg; treatment arm showed a more rapid and pronounced increase in plasma fibrinogen levels as measured both by the Clauss assay and by thromboelastometry (FIBTEM).
Safety parameters were comparable between the two treatment arms, although there were only 6 serious adverse events (SAEs) in the fibryga&reg; arm compared with 17 SAEs in the cryoprecipitate arm. Importantly, all SAE were judged as being unrelated to the treatment.
Importantly, fibryga&reg; was administered an average of 24 minutes earlier than cryoprecipitate. This reflects the rapid reconstitution and convenient use of fibryga&reg;.
The data from the FORMA-05 study demonstrate that fibryga&reg; is efficacious in patients with AFD and with no safety concerns. Data from the study have been accepted for publication in JTH1 (publication in process) and are complemented by similar results from the Canadian FIBRES randomised controlled trial,2&nbsp;which recently demonstrated non-inferiority of fibryga&reg; to cryoprecipitate for the treatment of AFD during cardiac surgery.

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