Grifols Advances New Fibrinogen Treatment with BLA Submission to U.S. FDA

Grifols , has announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its innovative fibrinogen solution. This marks a significant milestone in the company’s efforts to bring a new treatment option for acquired fibrinogen deficiency to U.S. patients.

This submission follows the European submission of a Marketing Authorization Application (MAA) in October 2024, with Grifols targeting a commercial rollout in Europe by the second half of 2025. If approved, the U.S. launch is anticipated for the first half of 2026.

A New Approach to Treating Fibrinogen Deficiency

The newly developed fibrinogen solution is designed to be both more convenient and faster to prepare than current alternatives. Acquired fibrinogen deficiency is a serious condition that impairs the body’s ability to stop bleeding, and it can lead to life-threatening complications, particularly in patients experiencing severe blood loss during surgery or trauma.

Grifols' new fibrinogen treatment, which can be stored at room temperature, offers advantages over current therapies such as cryoprecipitate or fresh frozen plasma, which require colder storage and are more time-consuming to prepare. These features make the new solution an attractive option in emergency settings, where every minute counts.

Phase III Trial Success

In February 2024, Grifols, in collaboration with its Grifols Group company Biotest, announced that its fibrinogen solution had demonstrated positive results in a pivotal Phase III clinical trial. The study successfully met its primary endpoint, showing that the new treatment was as effective as the standard of care in reducing intraoperative blood loss in patients with acquired fibrinogen deficiency. Additionally, the solution maintained an excellent safety profile, reinforcing its potential as a reliable therapeutic option.

What’s Next: Regulatory Timelines and Future Rollout

Grifols is making significant strides toward bringing this new fibrinogen solution to the market. Following the European MAA submission in October 2024, the company expects to begin treating patients in Europe by the second half of 2025. In the U.S., Grifols is hopeful for approval in time for a launch in the first part of 2026.

This potential treatment represents an exciting advancement in the management of acquired fibrinogen deficiency and is set to offer significant improvements in both the speed and ease of treatment administration, particularly in critical care environments.

Conclusion

Grifols’ submission to the U.S. FDA is a crucial step in the development of a more effective, accessible, and convenient fibrinogen therapy for patients in need. With the backing of successful clinical trial data and an innovative approach to fibrinogen delivery, Grifols is poised to address a significant unmet medical need in critical care settings.