Fibryga® approved for acquired fibrinogen deficiency in Europe
New clinical data support efficacy of fibrinogen concentrate (fibryga®) in treating acquired fibrinogen deficiency and lead to label extension in Europe
Fibrinogen replacement is widely accepted as an approach to managing acquired fibrinogen deficiency (AFD) in patients with critical bleeding, despite a lack of evidence until now from controlled clinical studies. Data from two comparative studies with Octapharma's highly-purified, dual pathogen-inactivated fibrinogen concentrate fibryga® have recently been published, and provide robust clinical support for this treatment approach.
The outcomes of a randomised, controlled clinical trial investigating approaches to bleeding control during cytoreductive surgery in 55 patients with pseudomyxoma peritonei were presented at the ISTH 2019 Congress in July. Fibrinogen replacement was effective for treatment of AFD in all cases, as measured by overall haemostatic efficacy. The results demonstrated non-inferiority of fibryga® (n = 22) compared with cryoprecipitate (n = 23) (p < 0.0095 for non-inferiority).
More recently, data from the first large multicentre, randomised controlled trial in AFD were published (JAMA, 2019). In a study of 827 patients undergoing cardiac surgery, fibryga® met the non-inferiority endpoint compared with cryoprecipitate (p < 0.001 for non-inferiority). Safety profiles of fibryga® and cryoprecipitate were comparable. Based on these clinical data, fibryga® received approval in the European Union for treatment of acquired fibrinogen deficiencies.
Read more at www.fibrinogendeficiency.com.