Grifols Receives FDA Approval for Pediatric Surgical Bleeding Fibrin Sealant

Barcelona-based multinational pharmaceutical and biologicals company Grifols announced on Thursday, August 11, 2022 that it has received approval from the United States Food and Drug Administration (FDA) to use its fibrin sealant solution to treat surgical bleeding in pediatric patients.

The company submitted a Biologics License Application (BLA) to the FDA for review in November 2021. The application was based on data from a Phase 3 clinical trial that evaluated the safety and efficacy of the fibrin sealant in pediatric patients undergoing surgery.

The Phase 3 trial, which included 250 patients, met its primary endpoint of reducing bleeding and the need for blood transfusions.

The fibrin sealant is a topical hemostatic agent that is applied to surgical sites to stop bleeding. It is made from human plasma and contains fibrinogen, thrombin, and other proteins that are involved in the blood clotting process.

The FDA approval is a significant milestone for Grifols, as it allows the company to expand the use of its fibrin sealant to a new patient population. The company believes that the fibrin sealant has the potential to improve outcomes for pediatric patients undergoing surgery by reducing bleeding and the need for blood transfusions.