Swissmedic has granted marketing authorization for Octapharma’s new fibrinogen concentrate product fibryga for the treatment of congenital and acquired fibrinogen deficiencies.
This approval is an important achievement for the company and most importantly, represents major progress for patients and physicians.
Octapharma board member Olaf Walter said: “The development of fibryga illustrates Octapharma’s continued commitment to improve the lives of our patients.
“The outstanding result of the clinical trial and the approval by Swissmedic is a great milestone for the company, as well as for the treating physicians, but most of all for the patients suffering from critical bleeding.”
“With fibryga we have amended our bleeding management portfolio addressing the need for a fast and reliable control of bleeding by the replacement of fibrinogen.”
Fibrinogen plays an important role in the coagulation system. Also known as coagulation factor I, fibrinogen is relevant for the initiation and propagation of building a firm blood clot. In addition to rare congenital fibrinogen deficiencies, there are significant numbers of patients with bleeding complications in surgeries and trauma caused by acquired low levels of fibrinogen.
Fibryga is a lyophilized fibrinogen concentrate for intravenous infusion, produced from pooled human plasma. The key features of the product are the purity, the unaltered functionality of fibrinogen, and a high level of pathogen safety.
Fibryga also allows a fast response to bleeding by a short and convenient reconstitution process. The product is indicated for the treatment of patients with congenital fibrinogen deficiencies, as well as patients experiencing severe bleeding related to acquire fibrinogen deficiency during surgical interventions and trauma.
UK’s Basingstoke Hospital haemotologist Dr Ashok Roy said: “Prospective controlled clinical trials provide the most robust support for clinician’s treatment decisions. So far, there has been limited controlled clinical evidence to support rational treatment for patients with fibrinogen deficiency.
“We are excited to see the excellent results of our study programme in patients experiencing massive surgical blood loss during cytoreductive surgery in pseudomyxoma peritonei. The results from the study are extremely important to help clinicians understand the importance of fibrinogen replacement in massively bleeding patients.”
The speed at which fibryga reconstitutes, thus is available to patients at the bedside, combined with its high quality and safety profile, is critically important. This will enable clinicians to use it with confidence and be a step forward in treating patients with acquired hypofibrinogenaemia. The data also inspires further research to better understand the management of critical bleeding.” Dr. Roy points out.
Fibryga is a novel fibrinogen concentrate produced from pooled plasma providing fast reconstitution, high level of safety, purity, and functionality for the treatment of patients where fast and efficacious replacement of fibrinogen is needed. Indication of use may differ by country.
Source: Company Press Release