Lachen/Paramus – The US FDA has expanded the approval of the bleeding control solution Fibryga. Developed by Octapharma, the solutions can now also be used for bleeding patients with acquired fibrinogen deficiency.

Octapharma USA, Inc. has announced that the US Food and Drug Administration (FDA) has awarded expanded approval for its product Fibryga. According to a press release issued by Octapharma, which is headquartered in Lachen in the canton of Schwyz, Switzerland, and has a subsidiary based in Paramus in the US State of New Jersey, the powdered solution can now also be used to treat bleeding patients with acquired fibrinogen deficiency (AFD). The clotting factor fibrinogen helps to stop bleeding.

This makes Octapharma’s fibrinogen concentrate, which is the only such product to be derived from human plasma and virus-inactivated, a faster and more precise option for severe bleeding than the current standard of care, cryoprecipitate, as the press release explains. First introduced in 1964, cryoprecipitate has significant disadvantages, according to the press release. These include a lengthy thawing and preparation process, variable fibrinogen levels, the inclusion of additional coagulation-dependent components and a higher risk of virus transmission.

“In the surgical theater, time matters”, comments Flemming Nielsen, President of Octapharma USA, in the press release. “This expanded FDA approval of Fibryga 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”, he adds.

Fibryga had already been authorized for the treatment of AFD in the European Union (2019) and in Canada (2020). The latest approval is the third secured for Fibryga to date. In 2017, the FDA approved it for acute bleeding episodes in adults and adolescents with fibrinogen deficiency, with a second approval coming in 2020 for pediatric patients under the age of 12 to treat acute bleeding episodes. ce/gba