Biologics License Grifols Advances Fibrinogen Solution with U.S. FDA Submission
Biologics License Grifols a global healthcare company and leading manufacturer of plasma-derived medicines, has announced the submission of a Biologics License Application (BLA) for its innovative fibrinogen treatment to the United States Food and Drug Administration (FDA). This submission represents a significant milestone in Grifols’ efforts to provide groundbreaking solutions for managing acquired fibrinogen deficiency.
In addition to the BLA submission, Biologics License Grifols filed a Marketing Authorization Application (MAA) with European regulatory authorities in October 2024. This simultaneous effort highlights the company’s commitment to addressing global healthcare needs. Pending regulatory approvals, Grifols aims to begin treating patients in Europe in the second half of 2025, followed by a planned rollout in the United States in early 2026.
Biologics License The fibrinogen treatment has shown exceptional promise, supported by robust clinical data. In February 2024, Grifols, in collaboration with Biotest—a Grifols Group company—announced positive topline results from a pivotal phase 3 clinical trial. The trial demonstrated that the fibrinogen treatment met its primary endpoint by proving as effective as the standard of care in reducing intraoperative blood loss in patients with acquired fibrinogen deficiency. Furthermore, it maintained an excellent safety profile, reinforcing its potential as a best-in-class solution.
Addressing a Critical Medical Need
Biologics License Acquired fibrinogen deficiency is a serious medical condition that compromises the body’s ability to form blood clots, posing life-threatening risks during severe bleeding episodes. Current treatment options, such as cryoprecipitate or fresh frozen plasma, are effective but often come with limitations, including preparation time and storage requirements. Grifols’ fibrinogen treatment offers a game-changing alternative by addressing these shortcomings.
“A fibrinogen deficit impedes the body’s ability to arrest bleeding, which can lead to death in severe situations,” explained Dr. Jörg Schüttrumpf, Grifols Chief Scientific Innovation Officer. “Grifols developed its new fibrinogen to be more convenient, faster to prepare, and storable at room temperature—an advantage over alternatives when time is of the essence. We’re excited to get this innovative solution to patients.”
Key Advantages of Grifols’ Fibrinogen Solution
Grifols’ new fibrinogen product sets itself apart in several critical ways:
- Enhanced Convenience: Unlike cryoprecipitate or fresh frozen plasma, which require thawing and preparation, the new fibrinogen is faster to prepare, making it ideal for emergency situations.
- Room-Temperature Storage: The ability to store the product at room temperature simplifies logistics and ensures availability in diverse healthcare settings.
- Safety and Efficacy: The phase 3 clinical trial confirmed that the fibrinogen is not only effective in reducing blood loss but also maintains a strong safety profile, critical for patient confidence and regulatory approval.
A Collaborative Effort
The development of this Biologics License fibrinogen treatment represents a collaborative achievement between Grifols and Biotest. Biotest, acquired by Grifols in recent years, has contributed significantly to the research and development of plasma-derived therapies. This partnership underscores Grifols’ strategic focus on innovation and its ability to leverage synergies within its group companies.
“The collaboration with Biotest has been pivotal in accelerating the development of this new treatment,” noted Dr. Schüttrumpf. “Together, we’ve combined expertise and resources to address a critical unmet medical need effectively.”
Global Implications and Market Potential
Grifols’ fibrinogen treatment has the potential to transform the management of acquired fibrinogen deficiency worldwide. By offering a superior alternative to existing therapies, it is expected to address significant gaps in emergency and surgical care. The global market for plasma-derived therapies continues to grow, driven by increasing awareness of rare and life-threatening conditions. Grifols is well-positioned to capitalize on this trend, bolstered by its strong portfolio and commitment to innovation.
The rollout of the fibrinogen treatment in Europe and the United States is anticipated to have far-reaching implications. Hospitals and emergency care providers will benefit from a more efficient and effective solution, ultimately improving patient outcomes. Moreover, the ability to store the product at room temperature reduces logistical challenges, particularly in resource-limited settings.
