Octapharma receives Swissmedic approval for fibryga® to treat congenital and acquired fibrinogen deficiencies26.11.2018
Lachen, Switzerland – 26 November 2018 – Octapharma today announced that the Swiss Agency for Therapeutic Products, Swissmedic, granted marketing authorization to its 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.
“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,” Olaf Walter, Board Member said. “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.
“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,” Dr. Ashok Roy, Haemotologist at Basingstoke Hospital, UK, says. “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. Please consult local product information for country specific information.
The vision of Octapharma is “Our passion drives us to provide new health solutions advancing human life”. Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. As a family-owned company, Octapharma believes in investing to make a difference in people’s lives and has been doing so since 1983; because it’s in our blood. Our company values are Ownership, Integrity, Leadership, Sustainability and Entrepreneurship.
In 2017, the Group achieved €1.72 billion in revenue, an operating income of €349 million and invested €287 million to ensure future prosperity. Octapharma employs around 8 000 people worldwide to support the treatment of patients in 113 countries with products across three therapeutic areas:
· Haematology (coagulation disorders)
· Immunotherapy (immune disorders)
· Critical care
Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden.
For more information visit www.octapharma.com