Setting new standards in patient bleeding management

Octapharma has received US Food and Drug Administration (FDA) approval of Octapharma's human fibrinogen concentrate for the treatment of acquired fibrinogen deficiency (AFD) – a condition that compromises blood clot formation and heightens the risk of severe haemorrhage. It is the first drug to gain FDA approval for this therapeutic class.

In major bleeding and especially in traumatic injury, the "golden hour" – the first hour after injury – is particularly critical. Survival rates increase significantly when treatment is provided within this window. Fibrinogen is a critical protein in coagulation, and the first constituent of the coagulation cascade to drop to dangerously low levels during major bleeding episodes. Rapid replenishment is essential for achieving hemostasis in emergency and surgical settings.

For patients experiencing major bleeding, studies indicate that administering coagulation therapy within the first 30 minutes can reduce complications and improve recovery rates in 70% of cases.¹

A safer alternative

The traditional standard blood product for replacing fibrinogen has for decades been cryoprecipitate. However, this allogenic transfusion product has serious limitations such as lengthy preparation times, variable fibrinogen levels and risks associated with viral transmission. By comparison, the purified and pathogen-inactivated fibrinogen concentrate offers a precise, consistent, and quickly-reconstitutable solution. As a lyophilised powder, it can be stored at room temperature or refrigerated, ensuring it’s ready when every second counts.

"In the surgical theatre, time and confidence matters,” says Flemming Nielsen, President, Octapharma USA, Inc. “This expanded FDA approval of our human fibrinogen concentrate represents a significant step forward in our commitment to redefining the standard of care for patients experiencing major bleeding. It provides an important option to hospitals, anaesthesiologists, surgeons and obstetricians / gynecologists across the United States who must act urgently and set a new standard of care for patients."

Pivotal to this achievement was the FIBRES trial - a multi-centre, randomised clinical study comparing Octapharma's human fibrinogen concentrate to cryoprecipitate in bleeding patients undergoing cardiac surgery. The trial demonstrated that human fibrinogen concentrate is effective in rapidly restoring fibrinogen levels, which is crucial in managing acute bleeding events.

"Octapharma's human fibrinogen concentrate offers a purified, virus-inactivated fibrinogen concentrate that can be administered quickly and precisely. This is vital in emergency situations where time and accuracy are of the essence," explains Dr Adam Gerber, Director of Scientific and Medical Affairs, Critical Care.

The importance of collaboration in securing FDA approval for Octapharma's human fibrinogen concentrate is highlighted by Dr Trupti Mehta Shah, Director of Scientific and Medical Affairs, Critical Care. She acknowledges that achieving this milestone required countless hours of hard work from the entire team, saying: "FDA approvals don’t happen overnight, but through numerous discussions with the regulators, along with dedication and teamwork, we made it happen.” With its expanded indication, Octapharma's human fibrinogen concentrate now provides clinicians with a reliable tool for managing AFD, ultimately improving patient outcomes.

Investing in innovation

Octapharma remains dedicated to continuous improvement and innovation - as highlighted by Flemming Nielsen, who emphasises the company's strategic ambition to further expand the accessibility of its therapies to more patients around the world. A key part of this strategy is also anticipating future healthcare challenges and delivering solutions that align with Octapharma’s vision of advancing human life.

The FDA approvals in 2024 reflect this commitment, with Octapharma's human fibrinogen concentrate joining other milestones, such as the approval of our 4-factor prothrombin complex concentrate and the Emergency Use Authorization (EUA) for lyophilised S/D treated plasma for military use.

The EUA for lyophilised S/D treated plasma demonstrates Octapharma's dedication to providing effective treatments in challenging environments, with Jason Brown - Marketing Director for Critical Care - emphasising: “Supporting our military personnel with the best care is a responsibility we take seriously.

With a broad portfolio of critical care solutions, Octapharma ensures timely access to the right treatments, focused on improving patient outcomes. As James Galloway, Senior Director Marketing for Acquired Bleeding, puts it, the aim is always to enhance patient health. This is a vision shared by Dr Mehta Shah, who adds, “The journey doesn't end here. We're motivated by the impact our work has on patient lives, and we're driven to push boundaries even further.”

^{1. ASH Publications. Assessment and management of massive bleeding: coagulation assessment, pharmacologic strategies, and transfusion management. Accessed January 17, 2025. https://ashpublications.org/hematology/article/2012/1/522/83841/assessment-and-management-of-massive-bleeding}