Octapharma receives FDA approval for new Fibryga formulation in AFD

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Source: Pharmaceutical Technology

Original: https://www.pharmaceutical-technology.com/news/octapharma-fda-approval-fibryga-f...

Published: Thu, 08 Jan 2026 10:07:36 +0000

Octapharma has received approval from the US Food and Drug Administration (FDA) for a new 2-gram formulation of Fibryga for patients with acquired fibrinogen deficiency (AFD).[2] The new 2g presentation complements the existing 1g version, giving clinicians two pack sizes.[2] The new package includes 100 ml of water for infusion (WFI) and the nextaro device for easier reconstitution of the drug.[2] Fibryga is a human fibrinogen concentrate in the form of a lyophilized powder that is quickly prepared for administration directly at the patient's bedside.[2] According to the article, it is the only virus-inactivated, human plasma-derived fibrinogen concentrate approved for the treatment of AFD in the US.[2] Fibryga is approved in the US for fibrinogen supplementation in patients with both acquired and congenital fibrinogen deficiency, including acute bleeding episodes in afibrinogenemia and hypofibrinogenemia.[2][7]