Octapharma USA has received expanded approval from the US Food and Drug Administration (FDA) for Fibryga (fibrinogen [human] lyophilised powder for reconstitution) to treat acquired fibrinogen deficiency (AFD).
Fibryga is now approved for use as a fibrinogen replacement therapy in bleeding AFD patients.
The drug is now said to be the first and only on-demand, virus-inactivated, human plasma-derived fibrinogen concentrate.
The latest approval is the third FDA authorisation for Fibryga to date. The first approval came in 2017 for managing acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
The second approval was granted in 2020 for its use in paediatric patients under 12 years old, specifically for treating acute bleeding episodes related to congenital fibrinogen deficiency.
Octapharma USA president Flemming Nielsen said: “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.
“We are proud to be the first to offer this therapeutic advancement—and a new standard of care—to hospitals, anaesthesiologists, surgeons, OB/GYNs, and patients across the US.”
The latest FDA expanded approval of Fibryga is based on the FIBRES [FIBrinogen REplenishment in Surgery] study, published in JAMA.
The head-to-head, multicentre, randomised clinical trial involved 735 patients.
According to the results, fibrinogen concentrate is non-inferior to cryoprecipitate and can be used as an alternative for treating bleeding related to AFD.
Fibryga has previously received regulatory approval for AFD treatment in the European Union in 2019 and in Canada in 2020.
The approval marks a significant advancement over the current standard of care. The lyophilised powder can be stored at room temperature or in the refrigerator and is quickly reconstituted at the point of care, Octapharma said.
Its formulation ensures a purified and consistent dose of fibrinogen for accurate and effective treatment.
In April, the FDA granted orphan drug exclusivity to Octapharma USA for wilate to treat adults and children aged six years and older with von Willebrand disease (VWD).
Octapharma USA is a unit of Switzerland-based Octapharma, a developer and producer of human proteins from human plasma and human cell lines.
