Grifols submits Biologics License Application for its new fibrinogen solution to U.S. FDA

Barcelona, Spain, Jan. 9, 2025 - Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global healthcare company and leading manufacturer of plasma-derived medicines, today announced it has submitted a Biologics License Application (BLA) for its new potential fibrinogen treatment to the United States Food and Drug Administration (FDA).

The European equivalent, a Marketing Authorization Application (MAA), was submitted for several countries in October 2024. Grifols expects to begin treating patients in Europe starting in the second half of 2025, with rollout in the U.S. planned for the first part of 2026.

In February 2024, Grifols and Biotest, a Grifols Group company, announced that the fibrinogen had achieved positive topline results in a phase 3 clinical trial. The study met its primary endpoint of being as effective as standard of care in reducing intraoperative blood loss in patients with acquired fibrinogen deficiency, while also maintaining an excellent safety profile.

“A fibrinogen deficit impedes the body’s ability to arrest bleeding, which can lead to death in severe situations,” said 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 such as cryoprecipitate or fresh frozen plasma when time is of the essence. We’re excited to get this innovative solution to patients.”