Octapharma receives FDA approval for new Fibryga formulation in AFD

The approval offers healthcare providers with an additional option alongside the existing 1g version.

The new kit contains 100ml Water for Infusion (WFI) and includes the nextaro reconstitution device, enabling streamlined preparation and increased dosing flexibility in urgent clinical settings.

Fibryga is said to be the sole virus-inactivated, human plasma-derived fibrinogen concentrate that received approval for AFD in the US.

Its lyophilised powder form enables quick reconstitution at the point of care, offering a substitute for cryoprecipitate, which has traditionally been used despite recognised limitations.

The expanded product line builds on Fibryga’s earlier FDA approval in 2024 for AFD. This approval was supported by the FIBRES study published in JAMA.

Octapharma president Flemming Nielsen said: “The introduction of the 2g Fibryga kit is a direct response to the needs of clinicians managing critical bleeding. By simplifying preparation and expanding dosing flexibility, we’re helping providers act faster and more precisely – when every second counts.”

Octapharma medical affairs vice-president Huub Kreuwel said: “Octapharma continues to invest in innovations that improve outcomes for patients with serious bleeding complications. The new 2g Fibryga kit is another step forward in our mission to redefine the standard of care in haemostasis.”

Fibryga has received approval in the US for use as fibrinogen supplementation in patients with congenital as well as acquired fibrinogen deficiency.

Indications include supplementation for bleeding patients with acquired fibrinogen deficiency, as well as treatment of acute bleeding episodes in those with congenital fibrinogen deficiency, including afibrinogenaemia.

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